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Ayush Ministry to amend D&C Rules mandating cGMP for homoeopathic drug manufacturing license

Ayush Ministry to amend D&C Rules mandating cGMP for homoeopathic drug manufacturing license

Posted on February 14, 2024 Updated on February 11, 2024

The Union Ministry of Ayush will soon amend the Drugs and Cosmetic Rules, 1945 to mandate good manufacturing practices for Homoeopathy drug manufacturing, stipulating procedures for loan licensing in the system of Homoeopathy and specifying timelines for issuance of license, among others.

The Ministry has issued a draft amendment rule, which also elaborates most aspects related to Homoeopathy in the Rules, apart from adding Sowa Rigpa to the group of Ayurveda, Siddha and Unani drugs in the principal rules.

The draft Drugs (Amendment) Rules, 2024, released by the Ministry seeking objections and suggestions of the stakeholders, has revised the Rule 85D for licensing of manufacture homoeopathic medicines to stipulate that the licence is issued only after fulfillment of the requirements of Good Manufacturing Practices (GMP) of Homoeopathic medicines as laid down in Schedule M1 of the Drugs Rules, 1945.

It freshly added a Rule 85BB on the application for certificate of Good Manufacturing Practices for Homoeopathic medicines manufacturing unit, mandating that the unit have premises and other requirements as prescribed under Schedule M1. The Certificate of GMP will remain valid unless it is cancelled by the licensing authority subject to deposit of a certificate retention fee of Rs. 1,000 before the expiry of a period of every succeeding five years from the date of its issue.

The draft rules also inserts a new clause of Rule 85BA related to application for loan license of manufacturing homoeopathic medicines, stipulating that the applicants need to submit the related form with a fee of Rs. 2,000 for any number of single ingredient Homoeopathic medicines and Rs. 200 per product for combination of ingredients.

“…notwithstanding the period of renewal, existing license holders under Form 25D prior to the date of commencement of the Drugs Rules, 2024 and such licence holder having a valid Good Manufacturing Practices Certificate as per Schedule T shall for the perpetuity of existing licence within a period of one year from the date of commencement of the Drugs Rules, 2024, by depositing a one time licence retention fee of rupees one thousand for existing licenced drugs falling under clause (a) of section 3 of the Act; and at the rate of rupees one hundred per product for existing licenced drugs falling under sub-clause (i) of clause (h) of section 3 of the Act,” says the draft amendment.

The draft rules changes the definition of Homoeopathic medicines, stating that any drug which is recorded in homoeopathic provings or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative literature of Homoeopathy as mentioned in first and second schedule of the Act and which is prepared according to the techniques of the official Homoeopathic Pharmacopoeia of India and abroad and covers combination of ingredients of such Homoeopathic medicines but does not include a medicine which is administered by parenteral route. It may be noted that the reference to Homoeopathic Pharmacopoeia of India was not there in the Rules so far.

The draft amendment substituted the requirements for import of new homoeopathic medicines, freshly adding that the combination of homoeopathic medicines which are not specified in any of the Pharmacopoeias referred in the Rules, or a combination of two or more Homoeopathic medicines even if individually mentioned in the official Homoeopathic Pharmacopoeia or in authoritative Homoeopathic books specified in the First Schedule of the Act, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims will also be considered as new homoeopathic medicines.

A New Homoeopathic Medicine shall continue to be considered as New Homoeopathic Medicine for a period of four years from the date of its first approval. However, the new rules are not applicable to the Homoeopathic medicine which has been issued approval for import or license for manufacture for sale in India prior to the date of this notification from the concerned State or Central Authority, and if such authority or person provides substantive information that the approval of competent authority has been obtained prior to the date of this notification.

The amendment also considerably increased the fee for various applications, including for the application to grant sales license to Rs. 2,000. It also has provisions to convert all application processes to online, through portal e-Aushadhi and till the portal shall come to effect, either offline or online process of license application shall be accepted.

It also stipulates that the sales and distribution license should be issued within a period of two months from the date of receipt of the application or from the date of fulfillment by the applicant of any shortcomings highlighted by the licensing authority. The duration of license issued shall remain valid perpetually, provided that the licensee submit a self declaration of adherence as per the regulations, every five years from the date of issue of license or from the date of submission of last self declaration.

The draft amendment freshly added that the licensing authority shall issue two reminders to licensee for submission of self declaration, six months and three months by Registered Post/Speed post with Acknowledgement Due and email, before the date of completion of every five years interval from the date of issue of license or from the date of issuance of such reminder.

If the self declaration is not made within three months of completion of five years from the date of issue of license in Form 20C or 20D or from the date of submission of last self declaration, the license shall be deemed to have been cancelled and the concerned party need to file a fresh application under Form 19B. With most of the licenses and approvals made perpetual subject to conditions, the draft rules omit many existing clauses related to renewal of approvals. The draft also elaborates the qualifications of the persons who can run the manufacturing facilities, among others.

The amendment also elaborates the definition of Registered Homoeopathy medical practitioner and Registered Ayurveda or Siddha or Sowa Rigpa or Unani medical practitioners. It also added the definition for Sowa-Rigpa drugs and proprietary medicines in the Rules.

The draft rules also propose inclusion of French Homoeopathic Pharmacopoeia and the European Pharmacopoeia under the standards on which the imports and manufacturing of homoeopathic drugs will be allowed in the country.

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