Cosmetics for Manufacturer Services in Delhi-- Ayush Ministry amends Rules to mandate renewal of manufacturing & loan license to perpetuity GireeshBabu, NewDelhi Monday, November 4, 2024, 08:00 Hrs [IST] The Union Ministry of Ayush has amended the Drugs and Cosmetics Rules, 1945 to mandate the existing manufacturers of Ayurveda, Siddha, Unani and Homoeopathy medicines to renew their manufacturing and loan licenses to perpetuity by depositing a one time retention fee, regardless of the period for their license renewal, within a period of one year. The Ministry has notified various amendments to the Rules, related to manufacturing and sales of Ayurveda, Siddha, Sowa Rigpa, Unani and Homoeopathic medicines. The amended rules, notified on October 28, have revised fees related to various applications, and added significant changes to the licensing procedures related to Homoeopathy systems of medicines. It has also added Sowa Rigpa to the group of Ayurveda, Siddha and Unani drugs, in the principal rules. The draft amendment to these changes was published in February, this year. The notification amends the provision in the Rule 153, related to application for license to manufacture Ayurvedic, Siddha and Unani drugs, stating that “…notwithstanding the period of renewal, existing license holders under Form 25D 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 license 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 licensed drugs falling under clause (a) of section 3 of the Act; and at the rate of rupees one hundred per product for existing licensed drugs falling under sub-clause (i) of clause (h) of section 3 of the Act”. Similar provisions have been added to the rules regarding loan licences and Rule 85B related to application for manufacturing license for Homoeopathic medicines. It removes the clause for renewal of license, and restructures the fee for application for manufacturing as Rs. 2, 000 for any number of single ingredient homoeopathic medicines, as defined in the relevant rules, and a fee of Rs. 200 per product for combination of ingredients of Homoeopathic medicines. Application for certificate of Good Manufacturing Practices for Homoeopathic medicines manufacturing unit has to be submitted along with a fee of Rs. 5, 000. The licence shall 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. Licence shall be granted by the licensing authority after consulting an expert committee in Homoeopathy, approved by the state government. The amendment also substitutes the definition of Homoeopathy, adds definitions of Sowa-Rigpa drugs and proprietary medicines, and updates the qualification of registered medical practitioners in Ayurveda, Siddha, Sowa Rigpa, Unani and Homoeopathy, following the formation of National Commissions for these systems of medicines. It also details the Rules related to import of new Homoeopathic medicines. All the applications should now be submitted through e-Aushadhi portal as per the format provided. The amendment also introduces rules regarding application for loan licence to manufacture Homoeopathic medicines, application for CGMP for Homoeopathic medicines manufacturing units, and duration of the GMP certificate (to be retained before the expiry of every succeeding five years from the date of issue), among others. There will be a late fee if the certificate retention fee is not paid on time. Online records of details mentioned under the rule and Schedule M-I shall also be accepted by the authority as valid documents. The amendment also approves 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.