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Business News›Industry›Healthcare/Biotech›Healthcare›New drugs regulatory bill
may be headed for cabinet next week

THE ECONOMIC TIMES DAILY NEWSPAPER IS AVAILABLE ONLINE NOW.

Read Today's Paper

NEW DRUGS REGULATORY BILL MAY BE HEADED FOR CABINET NEXT WEEK

SECTIONS
New drugs regulatory bill may be headed for cabinet next week
By
Teena Thacker

, ET BureauLast Updated: Aug 12, 2023, 09:23 AM IST
Synopsis

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.

ANIPeople buying medicines
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.

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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.

The Association of Indian Medical Device Industry (AiMeD), however, said
adequate discussions have not been held and the draft bill should be recalled.

The association has been asking for a separate chapter on medical devices under
the proposed law. "This was assured to us in 2016 and was in line with the
Parliament committee recommendations considering the huge potential of the
industry," said Rajiv Nath, forum co-ordinator, AiMed.

The association had also urged the health minister to recall the draft bill.

The government had set up a committee to frame new laws for medicines, medical
devices and cosmetics to replace the Drugs & Cosmetics Act, which was passed in
1940.

At present there is no distinction between the regulatory treatment of drugs and
medical devices.

The draft bill proposes medical device testing centres on the lines of drug
laboratories in states and at the central level.

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