28th October 2024, G.S.R. 669(E)

Here’s a breakdown of the key points from the “Drugs (Fifth Amendment) Rules, 2024” published in the Gazette, explained in simpler terms for easier implementation:

1. Title and Commencement

What it means: These new rules are called “Drugs (Fifth Amendment) Rules, 2024.” They come into effect immediately upon publication.

2. Broadening the Scope of Traditional Medicine Definitions

What it means: The rules now include “Sowa-Rigpa” (Tibetan medicine) alongside Ayurveda, Siddha, and Unani. This change appears throughout the document to update the mentions of these systems of medicine.

(a) Wherever “Ayurvedic, Siddha and Unani Drugs” appears, it’s replaced with “Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs”.
(b) Wherever “Ayurvedic (including Siddha) or Unani drugs” appears, it’s replaced with “Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs”.

3. Definitions – Key Changes

3(i) Homoeopathy Medicine:
What it means: This section redefines “Homoeopathy medicine.” It clarifies that it includes medicines used for various purposes (diagnosis, treatment, etc.) in humans and animals, based on established homoeopathic principles and books, and that it includes combinations of ingredients. It excludes drugs administered by injection.

3(ii) Registered Homoeopathy Medical Practitioner:
What it means: Updates the definition to include practitioners registered under the National Commission for Homoeopathy (NCH) Act, 2020.

3(iii) New Definitions for Ayurveda/Siddha/Sowa-Rigpa/Unani Medical Practitioners:
What it means: Defines “Registered Ayurveda or Siddha or Sowa-Rigpa or Unani medical practitioner” with qualifications from the Indian Medicine Central Council Act, 1970 or the National Commission for Indian System of Medicine (NCISM) Act, 2020, or those registered under these Acts.

3(iv) New Definitions for Sowa-Rigpa Drugs:
What it means: Defines “Sowa-Rigpa drugs” and “Sowa-Rigpa proprietary medicine.”

Sowa-Rigpa drugs: Medicines used internally or externally for treating diseases in humans or animals, made according to the formulas in the authoritative books of the Sowa-Rigpa system.
Sowa-Rigpa proprietary medicine: Formulations containing only ingredients from Sowa-Rigpa books. It excludes injectable medicines and formulations already listed in the authoritative books (as defined in 3(iv)).

4. Import of New Homoeopathic Medicines (Rule 30AA)

What it means: This section focuses on regulating the import of new homoeopathic medicines.

• Requirement: New homoeopathic medicines can only be imported with written permission from the Licensing Authority (defined in Rule 21(b)).
• Documentation: Importers must provide evidence of the medicine’s safety and effectiveness, including “homoeopathic provings”.
• Definition of “New Homoeopathic Medicine”:
  Medicines not listed in official pharmacopoeias (India, US, UK, Germany, France, or Europe). Medicines not recognized as effective in authoritative homoeopathic books. Combinations of medicines where one or more ingredients are not in the official pharmacopoeias or recognized books. Combinations of existing medicines in a new ratio, or with new claims.
• Duration: A medicine is considered “new” for five years after its first approval. After five years, it’s considered a regular homoeopathic medicine.
• Approval: The Licensing Authority approves the import if satisfied with the drug’s safety and effectiveness, after conducting necessary inquiries. They may request more data if needed.
• Exceptions: Medicines approved for import or manufacture before this notification are exempt, provided there’s proof of prior approval.
• Guidance: Guidelines from the Central Council for Research in Homoeopathy are to be followed.

5. Licensing for Sale of Homoeopathic Medicines (Rules 67A, 67C, 67E, 67EE)

67A – Application for License:
What it means: Applying for a license to sell/stock/distribute homoeopathic medicines:

• Use Form 19-B.
• Fee: ₹2,000.
• Application through the e-AUSHADHI portal (www.eaushadhi.gov.in). If the portal isn’t live, applications can be submitted offline.

67C – Forms of Licenses:
What it means: Licenses to sell homoeopathic medicines:

• Retail or wholesale licenses are issued in Form 20C or 20D.
• Licenses should be issued within two months of application or when any shortcomings are addressed.
• Application through the e-AUSHADHI portal. If the portal isn’t live, applications can be submitted offline.
• Exhibiting drugs for promotional activities in any fair does *not* require a license.

67E – License Validity:
What it means: License duration and renewal. Licenses in Form 20C or 20D are perpetual (valid forever).

• Licensees must submit a self-declaration of compliance with license conditions and the Drugs and Cosmetics Act every five years.
• The Licensing Authority will send reminders via Registered/Speed post and email.
• The self-declaration must be submitted within three months of the five-year mark.
• Failure to submit the declaration will result in license cancellation and the need to apply again using Form 19B.

67EE – Omitted (Removed)

6. Licensing for Manufacture of Homoeopathic Medicines (Rules 85B, 85BA, 85BB, 85D, 85E, 85EA, 85EB, 85EC, 85ED, 85F, 85FA, 85G, 85H)

85B – Application for License to Manufacture:
What it means: Applying for a license to manufacture homoeopathic medicines (includes fee structure):

• Form 24C is to be used.
• Fees: ₹2,000 for any number of single-ingredient homoeopathic medicines.
• ₹200 per product for combinations of ingredients of homoeopathic medicines.
• Portal: Applications to be submitted through e-AUSHADHI (www.e-aushadhi.gov.in). If the portal isn’t live, applications can be submitted offline.
• Important: Single ingredient Homoeopathic medicines with all of its potencies will be considered as one product and separate fees potency wise is not required.
  Sub-rules (3), (4), and (5) are omitted.

85BA – Application for Loan License:
What it means: Applying for a loan license (manufacturing using another manufacturer’s facilities):

• Form 24C1 is to be used.
• Fees are the same as for a manufacturing license.
• Applications to be submitted through e-AUSHADHI (www.e-aushadhi.gov.in). If the portal isn’t live, applications can be submitted offline.

85BB – Application for GMP Certificate:
What it means: Applying for a Certificate of Good Manufacturing Practices (GMP) for a homoeopathic manufacturing unit:

• Form 24C2 is to be used.
• Fee: ₹5,000.
• Requires the premises to meet Schedule M-I requirements.
• Applications to be submitted through e-AUSHADHI (www.e-aushadhi.gov.in). If the portal isn’t live, applications can be submitted offline.

85D – Form of License to Manufacture:
What it means: Forms for licenses to manufacture homoeopathic medicines:

• A license to manufacture is in Form 25-C.
• A loan license is in Form 25-C-1.
• Licenses are to be issued within two months.
• Licensing Authority consults an expert committee in homoeopathic systems of medicine.
• Applications to be submitted through e-AUSHADHI (www.e-aushadhi.gov.in). If the portal isn’t live, applications can be submitted offline.
  

85E – Qualification for License:
What it means: Qualification requirements for a manufacturing license:
The words “or renewal” and “or renewed” are removed.
(a) A graduate in Science with Chemistry or Botany or Zoology.
(c) A qualification as defined under the schedules of The National Commission for Homoeopathy (NCH) Act, 2020 (15 of 2020) with 18 months of experience in the manufacture of Homoeopathic medicines.

(2A) Certificate of Good Manufacturing Practice: Issued in Form 26C-1 if the manufacturer complies with Schedule M-I requirements.
The proviso under sub-rule (6) is omitted.

85EA – Inspections:
What it means: Inspection before granting or maintaining a manufacturing license or GMP certificate:

• The licensing authority will have the manufacturing site inspected by qualified inspectors (as defined in Rule 167).
• Inspections must be done at least once every five years, or as needed (risk-based approach).
• Inspectors should be assigned inspections randomly.
• If a site isn’t inspected within the GMP certificate’s validity, the certificate is automatically extended for five years upon submission of the retention fee.

85EB – Inspector’s Report:
What it means: The Inspector’s report:

• The inspector examines the premises, equipment, manufacturing processes, and staff qualifications.
• They verify information in the application.
• They provide a detailed report with findings and recommendations to the Licensing Authority.

85EC – Licensing Authority Procedure:
What it means: What the Licensing Authority does:

• If satisfied, the authority issues the license.
• If not satisfied, a “memorandum of shortcoming” is issued, and the conditions to be met are specified, along with a copy of the inspection report.
• The applicant has two months to respond.
• If the applicant doesn’t respond, the application is rejected.
• The process will be online through the e-AUSHADHI portal, but offline applications are accepted if the portal isn’t active.

85ED – Further Application After Rejection:
What it means: If an application is rejected:

• The applicant can reapply within six months, showing they’ve met the requirements, and paying an inspection fee of ₹1,000.
• A new inspection will be done, and the license or certificate will be issued if the conditions are met.

85F – Duration of License:
What it means: License duration:

• Licenses in Form 25C or 25C1 are perpetual (valid forever), unless suspended or cancelled.
• The licensee must ensure the validity of their GMP certificate.

85FA – Duration of GMP Certificate:
What it means: GMP Certificate duration:

• Certificates in Form 26C1 are valid unless cancelled by the Licensing Authority.
• A certificate retention fee of ₹1,000 must be paid every five years.
• Late fees apply for late payments.
• Non-payment leads to cancellation.

85G – Omitted (Removed)

85H – Responsibilities of a Licensee
What it means: Requirements for the Licensee

• (b) Inspectors are “qualified inspectors as mentioned under rule 167 appointed by the Central or State Government”.
• (d) Is Omitted.
  Additional proviso: Manufacturers maintaining online records are accepted.

7. Additional Rules and Amendments

106A:
What it means: Adding “French Homoeopathic Pharmacopoeia or the European Pharmacopeia” to the list of acceptable references for homoeopathic medicines.

153 & 153A (Ayurveda, Siddha, Unani):
What it means: These rules deal with licensing to manufacture Ayurveda, Siddha or Unani drugs. Fees, online portal and retention fee details are updated.

156C (Ayurveda, Siddha, Unani):
What it means: Before a GMP certificate (Form 26E-1) is granted, the manufacturing site will be inspected by qualified inspectors (Rule 167).

157 (Ayurveda, Siddha, Sowa-Rigpa, Unani):
What it means: Sets the requirements for competent technical staff supervising the manufacture of Ayurveda, Siddha, Sowa-Rigpa, or Unani drugs.

• Must have: A relevant degree in Ayurveda, Siddha, Sowa-Rigpa, or Unani medicine Or, a graduate in Pharmacy (Ayurveda/Siddha/Sowa-Rigpa/Unani) with two years’ experience in a licensed manufacturing unit.
• Exception: Existing competent persons are grandfathered in.

161B:
What it means: Clarifies that “Real time or accelerated” testing methods are acceptable.

162A:
What it means: Updates acceptable qualifications for Ayurveda, Siddha, Sowa-Rigpa, or Unani systems of Medicine.

168:
What it means: Changes the entry to “11.40%” in the table.

Schedule A:
What it means: Changes to the format of forms:

FORM 20C and 20D:
Changes the wording of item 2 (to reflect the date of enforcement).
Adds a space for the “License No”.

FORM 20E: Omitted (removed).

FORM 24C: The format is amended as per the new fees.

In Summary: These amendments primarily aim to:

• Incorporate Sowa-Rigpa medicine.
• Modernize licensing processes including the use of an online portal (e-AUSHADHI).
• Strengthen quality control with GMP requirements and inspections.
• Update definitions and references to include relevant new legislation and standards.
• Simplify and clarify licensing.