A case study can be defined as ‘ an intensive study about a person, a group of people or unite, which is aimed to generalize over several Unite. Procedural Violation (When procedure are purposefully deviated from or bypassed) are known to occur in a range are sometimes made with explicitly good intentions, violations, violations have been notes as a potential threat to patient safety. Individuals within a work system have often been judged as liabilities whose behavior may lead to accident.

The provision of detailed rules is often intended to minimize opportunity human error by limiting the freedom of choice is responding to a given situation, Violations from this prescription represent a deviation from the “Correct” way of working and introduce an element of risk to practice.

Objective

Procedural violation are known to occur in a range of work settings and are an important topic of interest with regard to safety management. A safety-I perspective see violations as undesirable digression from standardized procedures while a safety-II perspective see violations as adaptation to a complex work system. This study aimed to apply both perspectives to examination of violations in Community Pharmacists.

Case Study 1: Illegal Online Pharmacy Operations

Violation: Operating an online pharmacy without proper licenses, prescriptions, or adherence to regulatory guidelines.

Background:

In recent years, the proliferation of internet-based commerce has led to the emergence of numerous online pharmacies offering a wide range of prescription and non-prescription medications. While some online pharmacies operate legitimately, providing convenient access to medications for patients, others engage in illicit practices, including the sale of counterfeit, substandard, or unapproved drugs without the necessary regulatory oversight.

Case Details:

1. Investigation and Discovery:

Regulatory authorities received reports and complaints regarding suspicious online pharmacy websites selling prescription medications without requiring valid prescriptions or proper authorization. Initial investigations revealed that these websites were operating outside the boundaries of legal and regulatory frameworks governing pharmaceutical sales and distribution.

2. Identification of Violations:

Upon further investigation, it was determined that the online pharmacies were violating several key regulations and laws related to pharmacy operations, including:

• Selling prescription medications without requiring valid prescriptions from licensed healthcare professionals.
• Failing to obtain necessary licenses, permits, or approvals from regulatory authorities to operate as pharmacies or drug distributors.
• Disregarding patient safety by offering medications of dubious quality, potency, or authenticity without adequate quality control measures in place.

3. Collaborative Efforts:

Regulatory agencies collaborated with law enforcement authorities, internet service providers, and international agencies to identify the individuals and entities behind the illegal online pharmacy operations. This involved tracing the ownership, domain registration details, and financial transactions associated with the illicit websites.

4. Enforcement Actions:

Once the perpetrators were identified, regulatory agencies took swift and decisive enforcement actions to shut down the illegal online pharmacy operations. These actions included:

• Issuing cease and desist orders to the operators of the websites, directing them to immediately cease all unauthorized pharmaceutical sales activities.
• Collaborating with internet service providers to disable or block access to the illicit websites to prevent further dissemination of harmful products.
• Seizing assets, domain names, and financial accounts associated with the illegal online pharmacies to disrupt their operations and deter future violations.

5. Prosecution and Legal Consequences:

Individuals and entities involved in the illegal online pharmacy operations were subjected to legal proceedings and criminal prosecution. Charges were filed against them for violating pharmacy laws, consumer protection regulations, and other applicable statutes. Legal consequences included fines, penalties, asset forfeiture, and potential imprisonment for the most egregious offenders.

6. Public Awareness and Education:

Regulatory agencies launched public awareness campaigns to educate consumers about the risks associated with purchasing medications from unverified online sources. These campaigns emphasized the importance of obtaining prescriptions from licensed healthcare providers and purchasing medications only from reputable pharmacies with proper regulatory oversight.

Conclusion:

The case of illegal online pharmacy operations highlights the challenges posed by the digitalization of pharmaceutical commerce and the importance of robust regulatory enforcement to protect public health and safety. By taking decisive enforcement actions, collaborating across jurisdictions, and raising public awareness, regulatory authorities can mitigate the risks posed by illicit online pharmacies and safeguard the integrity of the pharmaceutical supply chain.

Case Study 2: Medical Termination of Pregnency

Introduction: Declining sex ratio is major concern in present time according to censes 2011 sex ratio in district Gwalior was 848 per male and in year 2011 it was 862 through there was marginal hike in sex ratio still district Gwalior is in bottom five district of lowest sex ratio.

Methodology

District adopted two prong approaches for deciling sex ratio, place where sex determination is being done is covered by active tracking devices along with online portal and the place where actual termination of pregnancy take place i.e. MTP centers are being guided by active monitoring this also included development of information system from these centers. Actively, secretly, promptly taking action on any information regarding female feticide was also a key to success.

Action taken

On date 26.11.2012 an information regarding MTP of more duration then permission to that particular center came in notice. After receiving such information an inspection team was formed in leadership of City Magistrate and C.M.H.O. Gwalior. This team suddenly inspected Shantikunj Nursing Home, at Gande wali Sadak own by Dr. K.K. Sharma. During inspection a pregnant female named Smt. Anju Sharma w/o Sh. Smuit Shamra age 28 yrs R/o Vadho wali gali Datia found admitted in this hospital.

During inspection it was found that MTP procedure namely catheter was inserted inside her uterus and no consent form of that pregnant lady was there in his hospital. During inspection Dr. K.K. Sharma told duration of pregnancy of 11 weeks but he cou’d not produce any of aunthetic document such as the referral form, Usg report, consent form or any other form in accordance to MTP act. During medical checkup of the pregnant female no such cause for MTP according to the act was found.

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Inspection team decided to call 108 ambulance and shifted to that patient to medical college hospital where evacuation of uterus was done as Dr. K.K. Sharma has already inserted the medicine for abortion.

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Postmortem of the fetus was done and age of fetus came out to be 16 weeks and 4 days and the fetus was a FEMALE FETUS. Medical college hospital also informed the same to Police station kampoo, gwalior. Shanti kunj Nursing home and Dr. K.K. Sharma were registered MTP practitioner there registration no. 64 dt. 6.7.2010 but he was having permission of MTP less than 12 weeks because that center was found and caught red handed for conducting an MTP more than 12 week without consent of patient. So case was registered at police station Indarganj under IPC act. Section 312 and MTP act section 3,4,5 for violation of MTP Act . FIR no. was 629/2012.

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As soon as this information came in local newspaper another female smt. Kirti Pathak w/o Deepak Singhal R/o Guda Gudi ka naka lashkar gwalior informed on telephone that her abortion more than 5 month was also conducted on the same Shantikunj Nursing home without her consent and his parents have kept her locked in her house. As soon as this information came to the administrative authorities they send the team to her house along with police and rescued her from her home. That female lodged an FIR against Dr. K.K Sharma under section 312,313 of IPC and section 3,4,5 of MTP act at police station indarganj.

For the first time in MP first case for violation of MTP act was filed in District Gwalior and registration of his Nursing Home and MTP registration was cancelled with immediate effect. This is a excellent example of quick action of distt.administration and due to this quick action awareness doveloped in pulbic in form of Smt.Kirti Pathak.

Conclusion and Advice

This is a known fact that female feticide is conducted by mutual coordination between USG Center and MTP Centers. To stop the female feticide both the centers should be monitored regularly, strictly and also sudden inspection should be conducted along with development of information system in the district regarding illegal abortion.

There should also be some cash prize reward as in PC& PNDT act for information of illegal abortion. very MTP Center should also keep an USG report before MTP so that specialist opinion about the age of fetus and cause for MTP can be justify.

Pregnancy due to failures of contraceptive method should be allowed till seven weeks only and such MTP should be done in only Govt. hospitals so that permanent methods of Family planning can be promoted and misuse of the act can be prevented. In presence scenario sex determination is a crime in PC&PNDT act but MTP act does not have any provision for female feticide.

To stop the female feticide we need an effective act including provision of MTP and PC&PNDT act both so that culprit doctors can be prosecuted and punished.

<p>The post Case studies – actions taken on violation of any act / rule related to pharmacy first appeared on PHARMA PUSH.</p>

A drug license, also known as a pharmaceutical license or a medicine license, is a legal authorization granted by the government or regulatory authorities to individuals or entities involved in the manufacturing, distribution, sale, or importation of pharmaceutical products. These licenses ensure that drugs meet specific safety, quality, and efficacy standards and are crucial for maintaining public health and safety.

The access to medicines and drugs must be restricted and regulated to ensure that such goods are not abused or misused by individuals. Thus, all pharmacists, wholesalers, retailers, manufacturers, sellers, dealers and importers of drugs, cosmetics, ayurvedic, Siddha and Unani drugs have to mandatorily obtain drug license under the Drugs and Cosmetics Act, 1940.

The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, help the government regulate and monitor the quality of drugs sold in India. The government exercises control over drugs from the raw material stage during manufacture, sale, distribution and till it is sold on to a patient or consumer by a pharmacist in a retail pharmacy, hospital or dispensary.

The government also exercises control in the aspects related to import and export of medicines, sale of the drug to a minor, consumption of schedule H & X drugs, etc., that requires thorough monitoring and cautious execution. The drug license is granted by the drug controlling authority under the Drugs and Cosmetics Act, 1940.

Types of Drug Licenses

In India, the following types of drug licenses are required, depending on the nature of the drug business:

• Manufacturing License: Issued to pharmaceutical companies or facilities engaged in the production of drugs. This license ensures that manufacturing processes comply with Good Manufacturing Practices (GMP).
• Wholesale License: Granted to wholesalers or distributors involved in the bulk distribution of pharmaceutical products.
• Retail License: Issued to pharmacies or drug stores allowing them to sell drugs directly to consumers. A retail license is required for the retail sale of drugs. A retail sale means the sale of drugs or cosmetics for the consumption of the end consumer. Retailers can sell it to a dispensary, hospital, educational, medical, or research institute. Retailers engaged in pharmaceuticals, cosmetics, stand-alone pharmacists, ayurvedic shops, etc need this license.
• Import License: Required for importing drugs from other countries to ensure compliance with local regulations.
• Export License: Needed for exporting pharmaceutical products to other countries, ensuring compliance with international regulations and standards.

Application for a Drug License

The drug controlling authority or the regulatory authority is responsible for issuing the drug license. The applicant must apply to the respective drug controlling authority based on the license he/she requires as each drug controlling authority is responsible to issue different licenses (as stated above). The following is the process for obtaining the drug license:

Visit the respective drug controlling authority website: The applicant must visit the respective drug controlling authority (SDSCO, CDSCO or Ayush) depending on the type of license he/she is applying for since each drug controlling authority is responsible for the issue of different types of drug licenses. 

Filing of application: The applicant must file the drug license application online on the respective drug controlling authority website. The applicant must fill all the details asked in the application form.

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Upload documents: After filling in the details on the application form, the next step is to upload the documents and submit the form along with the applicable fees. The applicant must keep all the documents updated before filing the application.

Visit by drug inspector: After receiving the application form, the drug Inspector will personally visit the company premises, shop or the drugstore for the verification of documents and correctness of facts stated in the application.

Grant of the drug license: After inspection and verification by the drug inspector, the drugs controller will issue the drug license.

List of Essential Documents For Obtaining a License

The specific documents required for obtaining a license may vary depending on the type of license and the regulations of the jurisdiction in which the license is being sought. However, here is a general list of essential documents often required for obtaining various types of licenses related to pharmaceuticals and drugs:

1. Application Form: A completed application form provided by the regulatory authority.
2. Proof of Legal Entity: Documents establishing the legal status of the entity applying for the license, such as a certificate of incorporation or registration.
3. Site Master File (SMF): A detailed document providing information about the manufacturing facility, including its layout, construction, equipment, utilities, and procedures.
4. Proof of Premises Ownership or Lease Agreement: Documents demonstrating ownership or legal occupancy of the premises where the pharmaceutical operations will be conducted.
5. Quality Management System (QMS) Documentation: Documentation outlining the quality management system implemented by the applicant, including standard operating procedures (SOPs), quality control processes, and quality assurance protocols.
6. Technical Staff Qualifications: Resumes, qualifications, and certifications of key technical personnel responsible for drug manufacturing, quality control, and regulatory compliance.
7. Good Manufacturing Practices (GMP) Compliance Documents: Evidence of compliance with GMP regulations, such as GMP certificates, audit reports, and validation records.
8. Equipment Calibration and Maintenance Records: Documentation demonstrating the calibration, maintenance, and validation of manufacturing equipment and instruments.
9. Quality Control Records: Records of quality control tests, including raw material testing, in-process testing, and finished product testing.
10. Packaging and Labeling Specifications: Specifications for packaging materials and labeling of pharmaceutical products, including artwork, product inserts, and package inserts.
11. Batch Manufacturing Records: Detailed records of each batch of pharmaceutical products manufactured, including batch records, production logs, and batch release documentation.
12. Stability Studies: Data from stability studies demonstrating the shelf-life and stability of pharmaceutical products under various storage conditions.
13. Environmental Impact Assessment (if applicable): Assessment of the potential environmental impact of pharmaceutical manufacturing operations, as required by environmental regulations.
14. Safety Data Sheets (SDS): Safety data sheets providing information on the hazards and safe handling of chemicals and pharmaceutical ingredients used in manufacturing.
15. Regulatory Approvals and Certificates: Copies of any regulatory approvals, certifications, or licenses obtained from other regulatory authorities.
16. Export and Import Documents (if applicable): Documents related to the import or export of pharmaceutical products, including import/export licenses, shipping documents, and customs declarations.
17. Financial Documents: Financial statements, bank statements, or proof of financial stability to demonstrate the financial viability of the applicant.

It’s important to consult with the specific regulatory authority or licensing agency in your jurisdiction to obtain the most accurate and up-to-date information regarding the required documents for obtaining a pharmaceutical license. Additionally, requirements may vary depending on the type of license and the nature of the pharmaceutical operations.

Forms to Obtain a Drug License

The following are different forms an applicant is required to fill according to the type of License required:

• Allopathic Drugs – FORM 20
• Restricted Allopathic Drugs – FORM 20-A
• Wholesale of Allopathic Medicines – FORM 20-B
• Retail of Homoeopathic Medicines – FORM 20-C
• Allopathic drugs mentioned in the Schedule C & C (1) – FORM 21
• Wholesale of Allopathic Medicines specified in the Schedule C & C (1) – FORM 21-B
• Retail sale of the Restricted Allopathic Medicines specified in the Schedule C (I) – FORM 21-A
• Retail Sale of Drugs specified in the Schedule ‘X’ – FORM 20-F
• Wholesale of Drugs Specified in the Schedule ‘X’ – FORM 20-G

In conclusion, obtaining a drug license is a critical process for individuals, companies, and entities involved in the manufacturing, distribution, sale, import, or export of pharmaceutical products. The specific forms required for obtaining a drug license vary depending on the jurisdiction and the type of license being sought. However, common forms include the application form, site master file, quality management system documentation, technical personnel information, equipment validation forms, batch manufacturing records, packaging and labeling specifications, stability study protocols, environmental impact assessments (if applicable), safety data sheets, and regulatory approvals and certificates.

<p>The post Licenses required, application processes (online/offline), drug regulatory office website of the respective state first appeared on PHARMA PUSH.</p>

Central Drugs Standard Control Organization (CDSCO)

As of my last update in January 2022, the official website of the Central Drugs Standard Control Organization (CDSCO) typically contains comprehensive information related to the regulation of pharmaceuticals and medical devices in India. CDSCO is the primary regulatory agency for pharmaceuticals and medical devices in India. Its website likely contains information about drug regulation, approvals, guidelines, notifications, and updates related to pharmaceuticals and medical devices in India.

Users may find details about drug registration procedures, import/export regulations, regulatory requirements for clinical trials, and pharmacovigilance. The website might also provide access to various forms, applications, and guidelines related to drug manufacturing, distribution, and sale. Here’s a general outline of what you might find on the CDSCO website:

1. About CDSCO:
   • Introduction to the organization, its mission, objectives, and structure.
   • Information about the regulatory functions of CDSCO in ensuring the safety, efficacy, and quality of drugs and medical devices.
2. Regulatory Framework:
   • Details about the laws, regulations, and guidelines governing the manufacture, import, distribution, and sale of drugs and medical devices in India.
   • Access to relevant acts, rules, and regulatory notifications issued by CDSCO.
3. Services and Procedures:
   • Guidelines and procedures for obtaining various regulatory approvals, licenses, and permissions from CDSCO.
   • Information about the submission of applications for new drug approvals, clinical trials, import licenses, manufacturing licenses, and marketing authorizations.
4. Publications and Resources:
   • Access to publications, guidance documents, and regulatory standards issued by CDSCO.
   • Frequently Asked Questions (FAQs) and user guides to assist stakeholders in understanding regulatory requirements and procedures.
5. Online Portals and Tools:
   • Links to online portals and tools developed by CDSCO for the submission of regulatory applications, tracking of applications, and accessing regulatory databases.
   • Information about the SUGAM portal for online submission of applications related to the import and registration of drugs and cosmetics.
6. News and Updates:
   • Announcements, news releases, and updates about regulatory developments, policy changes, and initiatives undertaken by CDSCO.
   • Information about upcoming events, workshops, and training programs organized by CDSCO for stakeholders in the pharmaceutical industry.
7. Contact Information:
   • Contact details of CDSCO offices across India, including addresses, phone numbers, and email addresses.
   • Guidelines for submitting queries, feedback, and grievances to CDSCO authorities.

It’s important to note that the layout and contents of the CDSCO website may evolve over time to reflect changes in regulatory requirements, policies, and technological advancements. For the most current and detailed information, I recommend visiting the official CDSCO website directly https://cdscoonline.gov.in/CDSCO/homepage.

Pharmacy Council of India

the official website of the Pharmacy Council of India (PCI) typically contains a range of information pertinent to the regulation of the pharmacy profession in India. PCI is the statutory body governing pharmacy education and practice in India. The PCI website typically includes information about pharmacy colleges, courses, syllabi, and regulations related to pharmacy education. Users might find details about registration procedures for pharmacists, renewal requirements, and codes of ethics for pharmacy practice. The website might also provide access to publications, research articles, and resources relevant to the pharmacy profession.

Additionally, there might be sections dedicated to news and events, announcements, and initiatives undertaken by PCI for the advancement of pharmacy education and practice. Here’s a general outline of what you might find on the PCI website:

1. About PCI:
   • Introduction to the Pharmacy Council of India, its establishment, functions, and objectives.
   • Overview of the role of PCI in regulating pharmacy education and practice in India.
2. Pharmacy Education:
   • Information about approved pharmacy colleges and institutions in India.
   • Details about the various pharmacy courses offered, including Diploma in Pharmacy (D.Pharm), Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm), and Doctor of Pharmacy (Pharm.D).
   • Guidelines and regulations for pharmacy education and curriculum development.
3. Registration and Licensing:
   • Procedures for the registration of pharmacists with the Pharmacy Council of India.
   • Requirements for obtaining pharmacist licenses and renewals.
   • Guidelines for foreign-trained pharmacists seeking registration in India.
4. Code of Ethics and Professional Conduct:
   • Code of ethics and professional conduct for pharmacists practicing in India.
   • Standards of professional behavior, responsibilities, and obligations of registered pharmacists.
5. Publications and Resources:
   • Access to publications, guidelines, and regulatory standards issued by the Pharmacy Council of India.
   • Resources for pharmacy educators, students, and practitioners, including research articles and educational materials.
6. News and Updates:
   • Announcements, circulars, and notifications related to pharmacy education, regulation, and practice.
   • Updates about changes in pharmacy curriculum, examination schedules, and regulatory policies.
7. Events and Workshops:
   • Information about conferences, seminars, workshops, and continuing education programs organized by PCI.
   • Details about upcoming events relevant to pharmacy education and practice.
8. Contact Information:
   • Contact details of the Pharmacy Council of India headquarters and regional offices.
   • Guidelines for contacting PCI officials, submitting queries, and accessing support services.

It’s important to note that the layout and contents of the PCI website may change over time to reflect updates in regulations, policies, and educational standards. For the most current and detailed information, I recommend visiting the official Pharmacy Council of India website directly https://www.pci.nic.in/.

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National Pharmaceuticals Pricing Authority (NPPA)

The National Pharmaceuticals Pricing Authority (NPPA) is an organization in India responsible for regulating the prices of pharmaceuticals to ensure that they are affordable and accessible to the general public. Here’s an overview of the NPPA and what you might find on its official website:

1. About NPPA:
   • Introduction to the National Pharmaceuticals Pricing Authority, its role, functions, and objectives.
   • Overview of the legal framework governing drug pricing in India, including the Drugs (Prices Control) Order (DPCO).
2. Drug Price Regulation:
   • Information about the process of drug price regulation and the methodologies used by NPPA to determine the prices of pharmaceuticals.
   • Details about the ceiling prices of essential drugs and formulations specified under the DPCO.
3. Notifications and Orders:
   • Access to notifications, orders, and circulars issued by NPPA regarding drug pricing, price revisions, and policy changes.
   • Information about the inclusion of new drugs in the National List of Essential Medicines (NLEM) and their pricing implications.
4. Online Resources and Tools:
   • Links to online resources and tools provided by NPPA for stakeholders to access information about drug prices, formulations, and regulatory updates.
   • Access to databases containing information about scheduled drugs, their prices, and regulatory status.
5. Compliance and Enforcement:
   • Guidelines for pharmaceutical companies, manufacturers, wholesalers, and retailers to ensure compliance with drug pricing regulations.
   • Information about penalties, fines, and enforcement actions taken by NPPA against entities found to be violating pricing norms.
6. Publications and Reports:
   • Access to reports, publications, and research studies related to pharmaceutical pricing, affordability, and access to medicines.
   • Analysis of trends in drug pricing and market dynamics in India.
7. FAQs and Resources:
   • Frequently Asked Questions (FAQs) addressing common queries related to drug pricing, regulatory processes, and compliance requirements.
   • Resources and guidance documents for stakeholders seeking clarity on NPPA’s regulations and procedures.
8. Contact Information:
   • Contact details of the National Pharmaceuticals Pricing Authority headquarters and regional offices.
   • Guidelines for submitting queries, complaints, and feedback to NPPA authorities.

The National Pharmaceutical Pricing Authority was set up as an attached office of the Department of Chemicals and Petrochemicals (now Department of Pharmaceuticals since July, 2008) on 29th August 1997. It has been entrusted interalia, with the following functions.

1. To implement and enforce the provisions of the Drugs Price Control Order (DPCO), 1995/2013  in accordance with the powers delegated to it.
2. To undertake and/or sponsor relevant studies in respect of pricing of drugs/formulations.
3. To monitor the availability of drugs, identify shortages, if any, and to take remedial steps.
4. To collect/maintain data on production, exports and imports, market share of individual companies, profitability of companies etc. for bulk drugs and formulations.
5. To deal with all legal matters arising out of the decisions of the Authority.
6. To render advice to the Central Government on changes/revisions in the drug policy.
7. To render assistance to the Central Government in the parliamentary matters relating to the drug pricing.

The layout and contents of the NPPA website may be periodically updated to reflect changes in drug pricing regulations, policies, and initiatives undertaken by the authority. For the most current and detailed information, it’s advisable to visit the official website of the National Pharmaceuticals Pricing Authority directly.

<p>The post Layout and contents of official websites of various agencies regulating the profession of pharmacy in India: e.g., CDSCO, SUGAM portal, PCI, etc first appeared on PHARMA PUSH.</p>

Ayurveda is the sacred system of health care originated in India. It is gaining widespread acceptability due to more affordable more closely corresponds to the patient’s ideology and less paternalistic than allopathic medicines. Earlier the practicing physicians used to prepare drug products by themselves for their patients.

Today drug products are usually prepared are packed by manufacturer and made available to pharmacy or physician or health care for sale or distribution. Drug and cosmetic act 1940 and rules 1945 have regulations for the manufacture for Ayurvedic drugs for sale or distribution. Factory means any premises engaged in manufacturing process employing ten or more workers with the aid of power or 20 or more workers without the aid of power.

Application for license to manufacture Ayurvedic Drugs

An application for the grant or renewal of a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24-D to the Licensing Authority along with a fee of rupees one thousand. In the case of renewal the applicant may apply for the renewal of the licence before its expiry or within one month of such expiry: Provided further that the applicant may apply for renewal after the expiry of one month but within three months of such expiry in which case the fee payable for renewal of such licence shall be rupees one thousand and two hundred plus an additional fee of rupees six hundred A fee of rupees three hundred shall be payable for a duplicate copy of a licence issued under this rule, if the original licence is defaced, damaged or lost.

Fees for an application for the grant of renewal of a loan licence to manufacture for sale of any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 25-E to the Licensing Authority along with a fee of rupees six hundred Provided that in the case of renewal the applicant may apply for the renewal of the licence before its expiry or within one month of such expiry: Provided further that the applicant may apply for renewal after the expiry of one month, but within three months of such expiry in which case the fee payable for renewal of such licences shall be rupees six hundred plus an additional fee of rupees three hundred. A fee of rupees one hundred and fifty shall be payable for a duplicate copy of a licence issued under this rule, if the original licence is defaced, damaged or lost.

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Inspection Fees for application for grant or renewal of approval for carrying out tests for identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs or the raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of the said Ayurvedic, Siddha and Unani drugs, is six thousand rupees.

Below is the required information as per the guidelines:

1. Company Information:
   • Legal Name of the Company: [Your Company Name]
   • Registered Address: [Your Company Address]
   • Contact Details: [Email Address], [Phone Number]
2. Key Personnel:
   • Name and Designation of the Authorized Person: [Your Full Name], [Your Designation]
   • Qualifications and Experience in Ayurvedic Drug Manufacturing: [Brief Description]
3. Infrastructure and Facilities:
   • Details of Manufacturing Unit: [Location, Size, and Facilities]
   • List of Machinery and Equipment: [Include a comprehensive list]
   • Adequate measures taken for Quality Control and Assurance: [Brief Description]
4. Product Information:
   • List of Ayurvedic drugs to be manufactured: [Provide a detailed list]
   • Formulation details and ingredients: [Include relevant details]
   • Compliance with Ayurvedic Pharmacopoeia: [Confirm adherence]
5. Quality Control Measures:
   • Description of Quality Control Laboratory: [Details of equipment, personnel, etc.]
   • Procedures for Quality Control of Raw Materials and Finished Products: [Describe procedures]
6. Documentation:
   • Details of Standard Operating Procedures (SOPs): [Include relevant SOPs]
   • Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR): [Sample records attached]
7. Compliance with Good Manufacturing Practices (GMP):
   • Steps taken to comply with GMP standards: [Provide relevant information]
8. Financial Stability:
   • Proof of financial stability to sustain Ayurvedic drug manufacturing: [Attach relevant financial documents]
9. Any Additional Information:
   • Any additional information required by the regulatory authority: [Include as necessary]

Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) is a set of guidelines and principles that ensure the production of safe, high-quality, and consistent products. GMP is crucial in various industries, including pharmaceuticals, food, cosmetics, and medical devices. Below are detailed elements of GMP:

1. Quality Management System (QMS):
   • Documentation and Records: Maintain comprehensive documentation, including standard operating procedures (SOPs), batch records, and quality control records. Document all processes, changes, and deviations.
   • Quality Policy and Objectives: Establish a quality policy that outlines the company’s commitment to GMP. Set quality objectives and regularly review performance against these objectives.
2. Personnel:
   • Qualifications and Training: Ensure that personnel are appropriately qualified and trained for their roles. Training programs should cover GMP principles, hygiene, and job-specific procedures.
   • Hygiene and Health: Implement practices to maintain personnel hygiene, including appropriate clothing, handwashing facilities, and health checks.
3. Premises:
   • Design and Layout: Design facilities to prevent contamination, mix-ups, and cross-contamination. Adequate space should be provided for each operation, with clear separation between different production areas.
   • Environmental Conditions: Control environmental conditions such as temperature, humidity, and cleanliness to ensure product integrity.
4. Equipment:
   • Qualification and Validation: Ensure that equipment is qualified and validated. Regularly calibrate and maintain equipment to prevent malfunctions.
   • Cleaning and Maintenance: Implement cleaning procedures and schedules for equipment. Document cleaning processes and verify their effectiveness.
5. Materials Management:
   • Raw Materials and Components: Source materials from approved suppliers. Verify the identity, quality, and purity of incoming materials.
   • Storage and Handling: Store materials under appropriate conditions to prevent contamination or deterioration. Implement a first-expiry-first-out (FEFO) system.
6. Production:
   • Batch Records: Maintain detailed batch records that document the production process, including equipment used, personnel involved, and any deviations from standard procedures.
   • Cross-Contamination Prevention: Implement measures to prevent cross-contamination, including dedicated equipment and facilities for certain products.
7. Quality Control:
   • Sampling and Testing: Establish procedures for sampling and testing raw materials, intermediates, and finished products. Ensure that testing methods are validated.
   • Stability Testing: Conduct stability studies to determine the shelf life of the product under recommended storage conditions.
8. Documentation and Records:
   • Change Control: Implement a change control system to manage any changes to processes, equipment, or facilities.
   • Deviation Management: Document and investigate any deviations from established procedures. Implement corrective and preventive actions (CAPA) as needed.
9. Outsourced Activities:
   • Contract Manufacturing and Testing: Ensure that any outsourced activities are performed by qualified and approved contractors. Maintain oversight and control over these activities.
10. Recall Procedures:
    • Establish procedures for product recall in case of identified quality issues. Clearly define responsibilities and actions to be taken during a recall.
11. Self-Inspection and Audits:
    • Conduct regular self-inspections and audits to ensure ongoing compliance with GMP. Address any findings and implement corrective actions.

Adherence to GMP principles is essential for regulatory compliance and, more importantly, for ensuring the safety, efficacy, and quality of products manufactured. It’s important to note that GMP requirements may vary between industries, so it’s crucial to be aware of and comply with the specific regulations applicable to your sector.

Competent Technical Staff

The manufacture of Ayurvedic drugs shall be conducted under the direction and supervision of competent technical staff consisting at least one person, who is whole time employee . Competent technical staff are a critical component of any organization, particularly in industries where technical expertise is essential.

Here are key aspects and qualities associated with competent technical staff:- Education and Qualifications, Experience, Analytical Skills, Communication Skills, Collaboration and Teamwork, Adaptability, Project Management Skills, Ethical Behavior, Customer Focus,… etc

Reference

1. Anonymous, The factory Act 1948. In: Taxmann’s Factory Act 1948, Delhi, Taxmann Publication Ltd. 2016.
2. Wikipedia Website

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Counterfeit or spurious medicines refer to drugs that are intentionally or fraudulently mislabeled with respect to their identity, composition, or source. These fake medications can be ineffective, unsafe, or even deadly, posing significant risks to public health. Counterfeit drugs may contain incorrect ingredients, incorrect doses, or no active ingredients at all.

Consequences of Substandard and Counterfeit Medicines

The consequences of substandard and counterfeit medicines can be understood through various theoretical perspectives, considering the impact on individuals, society, and the healthcare system. Here are some theoretical details to help explain the consequences:

1. Health Belief Model (HBM): The Health Belief Model posits that individuals take health-related actions based on their perceptions and beliefs. In the context of substandard and counterfeit medicines, if individuals believe that the medications they are purchasing are genuine and effective, they are more likely to adhere to treatment plans. However, if they unknowingly receive substandard or counterfeit drugs, it can lead to treatment failures and negative health outcomes.
2. Social Cognitive Theory (SCT): SCT emphasizes the role of observational learning and social influence in shaping behavior. In the case of counterfeit medicines, social factors such as peer influence, community norms, and trust in healthcare systems play a crucial role. If individuals observe others in their community using counterfeit drugs without apparent negative consequences, it may influence their own decisions, contributing to the widespread use of substandard medications.
3. Diffusion of Innovations Theory: This theory explores the process by which new ideas or innovations spread within a society. Counterfeit medicines can be considered a negative innovation that spreads through various channels, including illegal markets and unauthorized online pharmacies. The consequences of substandard medicines, such as treatment failures and health risks, can be seen as factors that hinder the successful adoption of genuine pharmaceutical innovations.
4. Structural Functionalism: This sociological perspective focuses on how institutions and structures contribute to the stability of society. The presence of substandard and counterfeit medicines can be seen as a dysfunction within the healthcare system. When the integrity of the pharmaceutical supply chain is compromised, it disrupts the smooth functioning of the healthcare system, leading to negative consequences such as increased healthcare costs, decreased trust, and compromised public health.
5. Risk Perception Theory: This theory suggests that individuals evaluate risks based on factors such as the severity of the consequences, their susceptibility, and their level of control. In the case of substandard and counterfeit medicines, individuals may underestimate the risks associated with purchasing medications from unauthorized sources. Lack of awareness and misinformation can contribute to a diminished perception of the potential harm, leading to continued use of counterfeit drugs.
6. Institutional Theory: From an institutional perspective, the presence of substandard and counterfeit medicines highlights failures in regulatory and institutional structures. Institutions responsible for regulating the pharmaceutical industry and ensuring the safety of medications may face challenges in enforcement and monitoring. Counterfeit drugs persist when institutions fail to effectively fulfill their roles, contributing to the erosion of public trust in these systems.

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Understanding the consequences of substandard and counterfeit medicines from these theoretical perspectives provides insights into the complex interplay of individual behaviors, societal influences, and institutional structures. Addressing the issue requires a comprehensive approach that considers not only individual decision-making but also the broader social, economic, and regulatory contexts.

Challenges to Preventing Counterfeit Medicines

Preventing counterfeit medicines poses several challenges, as the issue is complex and multifaceted. Some of the key challenges include:

1. Global Supply Chain Complexity: The pharmaceutical supply chain is highly complex, involving numerous stakeholders, from manufacturers to distributors to retailers. The global nature of the supply chain makes it challenging to monitor and regulate effectively, allowing counterfeit drugs to enter the system at various points.
2. Limited Regulatory Oversight: In some regions, regulatory authorities may lack the resources, infrastructure, or enforcement capabilities needed to effectively monitor and regulate the pharmaceutical industry. This creates loopholes that counterfeiters can exploit to introduce fake drugs into the market.
3. Lack of International Cooperation: Counterfeit medicine is a transnational issue that requires international collaboration. Limited cooperation among countries and regulatory bodies can hinder efforts to track and apprehend counterfeiters who may operate across borders.
4. Sophisticated Counterfeiting Techniques: Counterfeiters continually adapt and develop sophisticated techniques to mimic the appearance of genuine drugs. This includes replicating packaging, holograms, and other security features, making it difficult for consumers and even professionals to distinguish between genuine and counterfeit products.
5. Online Pharmacies and E-commerce: The rise of online pharmacies and the ease of e-commerce have facilitated the sale of counterfeit medicines. Illegitimate online platforms make it challenging to regulate and monitor the sale of medications, allowing counterfeit drugs to reach a broader audience.
6. Consumer Awareness and Education: Lack of awareness among consumers about the risks associated with counterfeit medicines is a significant challenge. Some individuals may unknowingly purchase medications from unverified sources due to ignorance or the pursuit of cost savings, contributing to the demand for counterfeit drugs.
7. Underreporting and Detection Challenges: Cases of counterfeit medicines often go underreported due to various factors, including the reluctance of victims to come forward, limited awareness, and challenges in detecting counterfeit products. This makes it difficult to assess the true extent of the problem.
8. Economic Incentives for Counterfeiters: Counterfeit drug production can be highly lucrative, offering significant financial rewards for criminal organizations. The potential for high profits provides a strong incentive for counterfeiters to continue their illegal activities.
9. Corruption and Weak Governance: Corruption within regulatory bodies or law enforcement agencies can compromise efforts to combat counterfeit medicines. Weak governance structures may lead to regulatory gaps and insufficient enforcement, allowing counterfeiters to operate with relative impunity.
10. Inadequate Technology and Infrastructure: Some regions may lack the technological infrastructure needed to implement advanced track-and-trace systems or other technologies that can help secure the pharmaceutical supply chain. Insufficient investment in technology hampers efforts to prevent and detect counterfeit medicines.

Factors encouraging counterfeiting of drugs

Several factors contribute to the encouragement of counterfeiting drugs. These factors are often interconnected and may vary in prevalence across different regions. Here are some key factors that facilitate the counterfeiting of drugs:

1. High Profit Margins: Counterfeit drugs can yield high profits for criminals with relatively low production costs. The potential for substantial financial gains serves as a significant incentive for engaging in the illicit trade of counterfeit medicines.
2. Globalization of the Pharmaceutical Supply Chain: The increasing globalization of the pharmaceutical supply chain has created opportunities for counterfeiters to exploit the complexity and lack of effective oversight. The extensive network of manufacturers, distributors, and retailers across multiple countries provides ample points of entry for counterfeit drugs.
3. Inadequate Regulatory Oversight: Insufficient regulatory oversight, particularly in certain regions or countries, creates an environment where counterfeiters can operate with less risk of detection and punishment. Weak regulatory frameworks may fail to deter or effectively penalize those involved in the production and distribution of counterfeit medicines.
4. Technological Advancements: While technology can be a tool for preventing counterfeiting, it also presents challenges. Counterfeiters leverage advanced technologies to replicate packaging, labels, and security features, making it harder for consumers and authorities to distinguish between genuine and fake drugs.
5. E-commerce and Online Pharmacies: The growth of e-commerce and the popularity of online pharmacies provide convenient platforms for the sale of counterfeit drugs. Illegitimate online vendors can reach a wide audience globally, allowing them to operate outside traditional regulatory frameworks.
6. Consumer Demand for Lower-Cost Medications: Economic considerations drive some individuals to seek lower-cost alternatives to prescription medications. This demand for cheaper drugs can lead consumers to purchase from unauthorized sources, increasing the risk of receiving counterfeit or substandard medicines.
7. Supply Chain Vulnerabilities: The pharmaceutical supply chain is susceptible to vulnerabilities at various stages, including manufacturing, transportation, and distribution. Counterfeiters exploit weak links in the supply chain to introduce fake drugs without detection.
8. Corruption and Weak Governance: Corruption within regulatory bodies, customs, or law enforcement agencies can undermine efforts to combat counterfeit medicines. Weak governance structures and inadequate enforcement mechanisms create an environment conducive to illegal activities.
9. Lack of Public Awareness: Insufficient awareness among the public about the risks associated with counterfeit medicines contributes to the demand for these products. Consumers who are unaware of the dangers may unknowingly purchase counterfeit drugs, especially when seeking lower prices.
10. Complexity of Legal Enforcement: Legal frameworks and enforcement mechanisms may be complex and challenging to implement effectively. Counterfeiters may exploit legal loopholes, and the intricacies of international law can make it difficult to prosecute those engaged in cross-border counterfeit drug operations.

Action to address substandard and Counterfeit Medicine

Addressing substandard and counterfeit medicines requires a comprehensive and coordinated approach involving multiple stakeholders, including governments, regulatory bodies, pharmaceutical manufacturers, healthcare professionals, law enforcement agencies, and international organizations. Here are key actions to address the issue:

1. Strengthen Regulatory Oversight:
   • Enhance regulatory frameworks to ensure robust oversight of the pharmaceutical industry.
   • Implement and enforce stringent regulatory standards for drug manufacturing, distribution, and sales.
   • Invest in regulatory capacity-building to enhance inspection and monitoring capabilities.
2. International Collaboration:
   • Foster international cooperation to share information, intelligence, and best practices.
   • Establish and strengthen partnerships between countries to combat cross-border counterfeit drug trafficking.
   • Collaborate with international organizations such as the World Health Organization (WHO) to develop global strategies.
3. Advanced Technologies and Track-and-Trace Systems:
   • Implement advanced technologies, such as track-and-trace systems and barcoding, to secure the pharmaceutical supply chain.
   • Explore the use of blockchain technology to create transparent and tamper-resistant supply chains.
   • Employ authentication technologies, such as holograms and serialization, on drug packaging.
4. Public Awareness Campaigns:
   • Educate the public about the risks associated with counterfeit medicines through awareness campaigns.
   • Promote the importance of purchasing medications from reputable sources, including authorized pharmacies and healthcare providers.
   • Provide information on how to identify genuine pharmaceutical products.
5. Enforcement and Legal Measures:
   • Strengthen legal frameworks and penalties for the production, distribution, and sale of counterfeit drugs.
   • Enhance cooperation between law enforcement agencies and regulatory bodies to investigate and prosecute offenders.
   • Facilitate the extradition of individuals involved in transnational counterfeit drug operations.
6. Monitoring and Surveillance:
   • Implement robust monitoring and surveillance systems to track the prevalence of substandard and counterfeit medicines.
   • Conduct regular inspections of pharmaceutical manufacturing facilities, distribution channels, and retail outlets.
   • Establish mechanisms for reporting and investigating suspected cases of counterfeit drugs.
7. Support for Developing Countries:
   • Provide assistance to developing countries to improve their regulatory infrastructure and capacity.
   • Facilitate technology transfer and knowledge sharing to enhance the ability of these countries to combat counterfeit medicines.
8. Collaboration with Industry:
   • Encourage collaboration between pharmaceutical companies, regulatory agencies, and law enforcement to share information and combat counterfeiting.
   • Implement measures to secure the supply chain at every stage of drug production and distribution.
9. Online Pharmacy Regulation:
   • Implement and enforce regulations governing online pharmacies to ensure the sale of genuine medications.
   • Collaborate with e-commerce platforms to monitor and remove illegal online pharmacies.
   • Educate consumers about the risks of purchasing medications from unverified online sources.
10. Investigation and Intelligence Gathering:
    • Invest in intelligence-gathering capabilities to identify and track criminal networks involved in counterfeit drug production and distribution.
    • Conduct thorough investigations to dismantle counterfeit drug operations and prosecute key individuals involved.

Addressing substandard and counterfeit medicines requires sustained efforts, collaboration, and a combination of regulatory, technological, and educational measures. A holistic approach is essential to safeguard public health and the integrity of the pharmaceutical supply chain.

Conclusion

• Global pharma companies are looking to India as a future growth prospect due to its fast growing economy, ageing population, growing middle-class, increasing presence of chronic diseases, inexpensive labour, and improving health care provision.
• However, the counterfeiting crisis is putting India at risk of losing foreign investments.
• Improvements to the regulatory landscape, and stricter punishments for manufacturers of counterfeits could significantly improve investor sentiment.
• Without strong rhetoric and action, India risks losing valuable investment from the pharmaceutical industry, and consequently, undermine the health of its population.

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Indian Pharmaceutical Industry is poised for high consistent growth over the next few years, driven by a multitude of factors. The pharmaceutical industry is a knowledge driven industry and is heavily dependent on Research and Development for new products and growth. However, basic research (discovering new molecules) is a time consuming and expensive process and is thus, dominated by large global multinationals.

Pharma Marketing Process and its Challenges

The pharmaceutical marketing process involves a series of interconnected steps designed to bring a pharmaceutical product from development to market and make it accessible to healthcare professionals and patients. However, this process is not without challenges, as the industry operates under stringent regulations and faces ethical considerations. Here’s an overview of the pharmaceutical marketing process and some of the challenges associated with each stage:

1. Research and Development (R&D):

• Challenge: R&D in the pharmaceutical industry is a lengthy and expensive process. Developing new drugs involves extensive research, clinical trials, and regulatory approvals, with no guarantee of success. High development costs and the risk of failure pose financial challenges for companies.

2. Regulatory Approval:

• Challenge: Obtaining regulatory approval is a time-consuming and resource-intensive process. The stringent requirements for safety and efficacy demand substantial data and documentation. Delays in approvals can affect market entry timing and competition with other products.

3. Branding and Positioning:

• Challenge: Differentiating a pharmaceutical product in a crowded market is challenging. Developing a strong brand identity and effective positioning requires understanding the unique value proposition of the drug and effectively communicating it to healthcare professionals and patients.

4. Sales Force and Distribution:

• Challenge: Managing an efficient sales force and distribution network is crucial. Companies must navigate the complex healthcare landscape, compliance with regulations, and varying practices across different regions and healthcare systems.

5. Direct-to-Consumer Advertising (DTCA):

• Challenge: Regulatory restrictions on direct-to-consumer advertising vary globally. Striking a balance between providing useful information to patients and avoiding misleading claims can be challenging. Ethical concerns also arise, especially when promoting prescription medications directly to consumers.

6. Medical Education and Sponsorship:

• Challenge: Balancing educational initiatives with potential conflicts of interest can be challenging. Ensuring that medical education remains unbiased and evidence-based while accepting industry sponsorship is an ongoing concern.

7. Patient Assistance Programs:

• Challenge: While patient assistance programs aim to enhance accessibility, challenges arise in determining eligibility criteria, reaching those in need, and sustaining long-term support. There may be concerns about programs influencing prescription behavior.

8. Digital Marketing and Online Presence:

• Challenge: Navigating digital marketing requires adherence to evolving regulations. Ensuring the accuracy of online information, managing social media engagement, and addressing concerns related to online privacy and data security are ongoing challenges.

9. Compliance and Regulatory Compliance:

• Challenge: Adhering to a myriad of regulations and compliance standards is a constant challenge. Missteps in advertising, reporting adverse events, or violating promotional guidelines can result in legal consequences and damage a company’s reputation.

10. Post-Marketing Surveillance:

• Challenge: Ongoing post-marketing surveillance is essential for monitoring the safety and efficacy of drugs. However, challenges include the identification and reporting of adverse events, ensuring timely communication, and implementing necessary safety measures.

Overall Industry Challenges:

1. Ethical Concerns:
   • Ensuring ethical conduct in marketing practices, avoiding conflicts of interest, and maintaining transparency are paramount.
2. Rising Healthcare Costs:
   • The high cost of pharmaceuticals and concerns about healthcare affordability raise challenges in pricing, reimbursement, and access to innovative treatments.
3. Generic Competition:
   • Once a drug’s patent expires, generic competition can significantly impact sales, prompting the need for strategic lifecycle management.
4. Market Access:
   • Gaining market access and reimbursement approval can be challenging, especially in healthcare systems with stringent cost-effectiveness evaluations.
5. Global Market Variability:
   • Differing regulatory requirements, healthcare systems, and cultural considerations across global markets pose challenges for companies operating on an international scale.

Successfully navigating these challenges requires a comprehensive understanding of the pharmaceutical industry’s complex landscape, ongoing adaptation to regulatory changes, and a commitment to ethical and patient-centric practices.

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Use of medical representatives for marketing products to physicians and to exert some influence over others in the hierarchy of decision makers has been a time-tested tradition. Typically, sales force expense comprises an estimated 15 percent to 20 percent of annual product revenues, the largest line item on the balance sheet. Despite this other expense, the industry is still plagued with some very serious strategic and operational level issues.

From organizational perspective the most prominent performance related issues are:

1. Increased competition and unethical practices adopted by some of the propaganda base companies.
2. Low level of customer knowledge (Doctors, Retailers, Wholesalers).
3. Poor customer (both external & internal) acquisition, development and retention strategies.
4. Varying customer perception.
5. The number and the quality of medical representatives.
6. Very high territory development costs.
7. High training and re-training costs of sales personnel.
8. Very high attrition rate of the sales personnel.
9. Busy doctors giving less time for sales calls.
10. Poor territory knowledge in terms of business value at medical representative level.
11. Unclear value of prescription from each doctor in the list of each sales person.
12. Unknown value of revenue from each retailer in the territory.
13. Absence of ideal mechanism of sales forecasting from field sales level, leading to huge deviations.

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