Draft Bill on regulating medical devices
- Drugs, Medical Devices and Cosmetics Bill, 2022 is proposed to replace The Drugs and Cosmetics Act, 1940, and several sets of Rules by which the industry is currently run.
Issues with e-pharmacies
- Currently working completely outside the law.
- Most of the websites have a license for physical shop or storage unit.
- In case of a violation, drug inspectors do not know under which provision of the law or Rule they can proceed against websites.
- They often find that licenses these websites hold are from another state, over which they have no jurisdiction
Key Highlights of the draft Bill
- No person shall sell, or stock or exhibit any drug by online mode except under and in accordance with a licence or permission issued
- Central government can formulate Rules to regulate industry.
- Regulating Medical devices
- Provides for creating a Medical Devices Technical Advisory Board.
- On lines of existing drugs technical advisory board
- Members: People with technical knowledge of engineering of these devices, members of industry, Officials of Health Ministry, Department of Atomic Energy, DST, MeiTY, DRDO, and experts from fields of biomedical technology, biomaterials, and polymer technology.
- Clinical trials and investigations
- Provides for compensation for injury or death suffered in clinical trials and investigations for drugs and medical devices.
- Imprisonment, and fine to double, if it is not paid.
- Debar investigators and sponsors of a trial if provisions aren’t followed.
- Bill has some critical gaps
- Fines aren’t enough to deter a big pharma company.
- Misses post-marketing surveillance, especially for medical devices.
- Need provisions for recalling medicines or devices if faulty.
- These are issues with the draft Bill which needs to be rectified.
- A law needs to be simple, reasonable, and implementable, and must not become a barrier to Make In India or Innovate in India.
- Drugs, Medical Devices and Cosmetics Bill, 2022