Newsletter

Ministry of Ayush have issued a Notification to amend the Drugs Rules, 1945 vide its GSR 669 (E) dated 28.10.2024. There are a few major changes effected, which will have to be noted by the stakeholders. The main highlights of the said notification are as under;

• Sowa-Rigpa, an Indian System of medicine is recognized. Accordingly, Sowa-Rigpa drugs and Sowa-Rigpa proprietary medicine are defined in relation with the authoritative books of Sowa-Rigpa system of medicine which are specified in the First Schedule of the Drugs and Cosmetics Act, 1940. This is the Schedule wherein the authoritative books of Ayurveda, Siddha, Unani are specified.
• However, the said First Schedule is yet to be amended to include the names of the authoritative books of Sowa-Rigpa and Homoeopathy systems of medicine.
• Fees for ASSU drugs rationalized and validity of the GMP Certificate to be maintained.
• Now, definition of Homoeopathy medicine is amended to bring in line with the definitions of other drugs, bringing more clarity and linking it to the intended use. Now, it also expands to the provings through research. It refers to the homoeopathy books specified in the first and Second Schedule of the Act. The Second Schedule prescribes the standards to be complied for the drugs which primarily refers to the Pharmacopoeias of India and other countries.
• Definition of Registered Ayurveda or Siddha or Sowa-Rigpa or Unani Medical Practitioner is inserted for the first time linking it to the registration and eligibility to be registered as per the registers and qualifications notified in the Schedules to the Indian Medicine Central Council Act, 1970 or National Commission for Indian System of Medicine Act, 2020.
• The safety and therapeutic efficacy will be assessed while permitting the import of the New Homoeopathic Medicine. Now, even combination of two or more Homoeopathic medicines mentioned in official Pharmacopoeia or authoritative books proposed to be combined for the first time will be considered as New Homoeopathic medicine and therefore, will require the permission of the Licensing Authority appointed by the Central Government.
• A New Homoeopathic Medicine shall continue to be considered as New Homoeopathic Medicine for a period of five years from the date of its first approval.
• Safety, therapeutic efficacy and minimum provings of Homoeopathic medicines shall be in accordance with the guidelines prescribed by Central Council for Research in Homoeopathy.
• French Homoeopathic Pharmacopoeia and European Pharmacopoeia are acceptable and recognized.
• Fees for the Licence for sale of Homoeopathic medicine by way of wholesale and retail is now increased from Rs 250/- to Rs 2000/- for each Licence.
• Applications for Licence to be made through portal e-AUSHADHI i.e. www.eaushadhi.gov.in from the date when it is notified. Licence to be issued within period of two months from the date of application.
• No license shall be required for exhibiting the drugs for promotional activities in any fair.
• Licence to remain valid perpetually, subject to submission of self declaration of adherence of conditions of Licence and provisions of Act and Rules every five years from grant of licence. Surprisingly, licensee do not require to pay any fees for retaining the validity of licence.
• Fees for manufacture of Homoeopathic medicines increased and rationalized as Rs 2000/- for any number of single ingredient Homoeopathic medicines and Rs 200/- per product for combination of ingredients of Homoeopathic medicines. For existing licensees having valid GMP Certificate, one year’s period is given for seeking perpetuity of validity of licence by paying Rs 1000/- for single ingredient products + Rs 100/- per combination product. Application to be made on e-AUSHADHI portal (www.aushadhi.gov.in) from the day of notification by the Central Government for portal.
• Now, provisions for Loan Licence for manufacture of Homoeopathic medicines are prescribed (Form 25-C-1).
• Application Form 24C2 prescribed for Certificate of GMP for Homoeopathic medicines with fees of Rs 5000/-.
• Procedure for inspection for grant of licence, GMP certification, report by inspector and procedure of Licensing Authority is revised and rationalized.
• Manufacturing Licence to remain valid in perpetuity, however, licensee to ensure the validity of GMP certificate for the facility by paying certificate retention fee of Rs 1000/- before expiry o every five years.
• Maintenance of online records of manufacturing is acceptable.
• Form 24 C, Form 25 C revised while Form 24C1, Form 24C2, Form 25C1 and Form 26C1 newly inserted.