The Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) has proposed draft rules to amend the Drugs and Cosmetics Rules, 1945. The notification was issued on 30th September 2020 and published in the Official Gazette on 1st October 2020.
AYUSH invites suggestions and objections to the draft rules from the general public within a period of 30 days. These must be addressed to the Secretary, Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), AYUSH Bhawan, ‘B’ Block, GPO Complex, INA, New Delhi – 110023.
The Draft Rules stipulate for some of the following prospective changes:
1. Omission of ‘sterilised surgical ligature and sterilised surgical suture’ from the purview of the Central Drugs Laboratory
The draft amendment seeks to remove ‘Sterilized surgical ligature and sterilised surgical suture’ from being under the purview of the Central Drugs Laboratory in general or the Central Research Institute, Kasauli in particular.
This means that testing, analyzing or performing any other duties in relation to sterilised surgical ligature and sterilised surgical suture will no longer fall under the functions of the Central Drugs Laboratory or the Central Research Institute, Kasauli.
2. Constitution of a Scientific Advisory Board for the Pharmacopoiea Commission of Indian Medicine & Homoeopathy
The Board is proposed to have a term of 3 years. It will perform an advisory function to the Central Government, the State Governments and the stakeholders on the matters of standards, SOPs (Standard Operating Procedures) and testing protocols of Ayurveda, Siddha, Unani and Homoeopathy Drugs.
The draft Rules suggest that the Board will comprise of a membership of 12 specified members, It will also recommend to the Pharmacopoiea Commission, the constitution of pharmacopoiea committees and sub-committees for a period of three years.
3. The laboratory of Pharmacopoeia Commission of Indian Medicine & Homoeopathy shall act as Central Appellate Drugs Laboratory
The Commission shall act as the Central Appellate Drugs Laboratory for the purpose of testing or analysis of samples of Ayurveda, Siddha, Unani and Homoeopathy Drugs.
The Central Drugs Laboratory will have to additionally perform the following functions:
- maintain reference museum and herbarium of Ayurveda, Siddha, Unani and Homoeopathy drugs,
- conduct training programmes for analytical and drugs quality control methods and
- carry out such activities and duties that are entrusted to it by the Central Government.
4. The laboratory of Pharmacopoeia Commission of Indian Medicine & Homoeopathy will replace the Pharmacopoeial Laboratory for Indian Medicine as the Central Drugs Laboratory for the purpose of testing or analysis of Ayurveda, Siddha and Unani Drugs
Samples for testing or analysis of Ayurveda, Siddha, Unani and Homoeopathy drug will be required to be sent to the Director, Pharmacopoeia Commission of Indian Medicine & Homoeopathy, Ghaziabad (Uttar Pradesh).
Prior to this proposed amendment, the samples were to be sent to the Director, Pharmacopoeial Laboratory for Indian Medicine.
The draft Rules also propose changes in the memorandums that are to accompany the samples and the certificates issued with the results of the tests or analysis.
5. Revision of qualifications and duties of Government Analyst and qualifications of Inspector
The draft Rules propose an additional postgraduate qualification in Ayurvedic Ras-shastra/Unani Saidala/ Siddha MarunthuAlunur/pharmacy for appointment of Government Analyst.
The draft Rules also omit the possession of a diploma as a qualification for appointment as Inspector.
6. Revision of fees for the test or analysis by the Central Drugs Laboratory of Indian Medicine & Homoeopathy or the Government Analyst
The draft Rules propose revisions of the fees prescribed for various tests and analysis.
