bill: New drugs regulatory bill may be headed for cabinet next week

bill: New drugs regulatory bill may be headed for cabinet next week

The Drugs, Medical Devices and Cosmetics Bill 2022, which seeks to repeal the 83-year-old Drugs and Cosmetics Act 1940 is likely to be placed before the Cabinet next week, said people with knowledge of the matter.

The Bill seeks to regulate the import, manufacture, distribution and sale of drugs, medical devices and cosmetics. It also seeks to ensure their quality, safety, efficacy, performance and clinical trials of new drugs and clinical investigation of investigational medical devices and clinical performance evaluation of new in-vitro diagnostic medical devices, including Ayurveda, Unani, Siddha, Sowa-Rigpa and homeopathy (AUSSH) drugs, medical devices and cosmetics.

The Centre has proposed creation of a new post of drugs, medical devices and controller general so that medical devices are dealt in a manner distinct from drugs with a separate chapter being provided for the same constitution of a medical devices officer separate from the drug control officer.

ET Bureau

It also envisages creation of a separate medical devices testing laboratories and medical devices testing officers.
Separate Drugs Technical Advisory Board and Medical Devices Technical Advisory Board have been proposed, as has Drugs, Medical Devices and Cosmetics Consultative Committee, along with specific provisions for compensation in case of injury or death of participant, along with the medical management of such participants.The draft had been in the works for a long time but was posted on the ministry’s website last year, and it received 9,000 comments and suggestions.The draft Bill proposes imprisonment and fine as punishment for manufacturing medicines without registration or for producing fake medicines. It also entails penal provisions for the devices which don’t meet prescribed standards.It also proposes an adjudicating authority and penal provisions which will be covered under adjudication for drugs which are not of standard quality or are misbranded. There are also penal penalties for failure to provide medical management and compensation in case of clinical trials and clinical investigation or clinical performance evaluation.

Health ministry officials held a meeting on Thursday with the pharma lobby groups – the Indian Drug Manufacturers’ Association, Indian Pharmaceutical Association, FICCI and CII to discuss the draft Bill.

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