Requirements for Ayurvedic, Homeopathic manufacturing, sale, and licensing requirements

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Introduction

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]
SL. NoForm No.Application
1.FORM 24DAppilication for grant/renewal of a licence to manufacture for sale of Ayurvedic/ Siddha or Unani drugs.
2.FORM 25DLicense to manufacture for sale of ayurvedic/ Siddha or Unani drugs.
3.FORM 26DCertificate of renewal of license to manufacture for sale of Ayurvedic/ Siddha or Unani drugs.
4.FORM 24EAppilication for grant or renewal of a licence to manufacture for sale of Ayurvedic/ Siddha or Unani drugs.
5.FORM 25ELoan Licence to manufacture for sale Ayurvedic including Siddha or Unani Drugs.
6.FORM 26ECertificate of renewal of license to manufacture for sale of Ayurvedic/ Siddha or Unani drugs.
7FORM 26E-ICertificate of Good Manufacturing Practices (GMP) to manufacture for sale of Ayurvedic/ Siddha or Unani drugs.
8FORM 26E2-IFree Sale Certificate
9FORM 26E2-IIFree Sale Certificate (Under Loan License)
10FORM 26E3Non-Conviction Certificate
11FORM 35Form in which the Inspection Book Shall Maintained
12Schedule TAForm for record of utilization of raw material by Ayurveda or Siddha or Unani Drugs.

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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