The Ministry of Health and Family Welfare on 8th July 2022, has proposes a draft of New Drugs, Medical Devices and Cosmetics Bill, 2022 with provisions to regulate medical devices, clinical trials and online pharmacy, among others in order to keep pace with changing needs, times, and technology as against the pre-independence legislation of the Drugs and Cosmetics Act, 1940.
Key Highlights from the Draft Bill:
- As per the Draft, no person shall himself or by any other person on his behalf sell, or stock or exhibit or offer for sale, or distribute, any drug by online mode except under and in accordance with a license or permission issued in such manner as may be prescribed.
- No person shall himself or by any other person on his behalf, manufacture for sale or distribution, or sell, stock, exhibit, offer for sale or distribute, any drug which is not of standard quality, or is misbranded, adulterated or spurious, cosmetic which is not of standard quality, or is misbranded, adulterated or spurious and proprietary medicine, unless there is displayed, on the label or container thereof the true formula or list of active ingredients contained in it together with the quantities thereof, in such manner as may be prescribed.
- Every person holding a licence shall keep and maintain such records, registers and other documents as may be prescribed and shall furnish to any officer or authority exercising any power or discharging any function under this Act such information as is required by such officer or authority for carrying out the purposes of this Act.
- For the import of drugs and cosmetics which are prohibited under the Act, officers of customs and officers empowered under the Customs Act, 1962, shall have the powers and the Commissioner of Customs or any officer authorised by the Government, may detain any imported package which he suspects to contain any prohibited drugs or cosmetics and shall report to the DCGI.
- No person shall by himself or by any other person on his behalf shall conduct any clinical trial in respect of a new drug, investigational new drug, bioavailability or bioequivalence study of any new drug, in human participants except under, and in accordance with, the permission granted by the Central Licensing Authority subject to such conditions and in such form and manner as may be prescribed.
- The Central Drug Regulatory authority for Ayurveda, Siddha, Sowa-Rigpa, Unani and Homoeopathy drugs, devices and cosmetic appointed by the Central Government shall regulate the manufacture and sale of Ayurveda, Siddha, SowaRigpa, Unani and Homoeopathy drugs.
- No person shall manufacture for sale or for distribution any Ayurvedic, Sowa Rigpa, Siddha Unani or Homoeopathic drug except in accordance with such standards, if any, as may be prescribed in relation to that drug.
- No marketer shall adopt any drug manufactured by another manufacturer for marketing of such drug by labelling or affixing his name on the label of the drug with a view for its sale and distribution without an agreement as prescribed in rules.
