A bill to replace the 1940 drugs law runs into the medical device industry

A bill to overhaul the Drugs and Cosmetics Act, 1940 is currently being circulated to stakeholder ministries, and it has run into sustained opposition from India's medical device sector. Pharmaceutical and device associations say no stakeholder consultation took place while the draft was being written, and that it is substantially the same bill circulated in 2022 and 2023 with only cosmetic changes.

The Association of Indian Medical Device Industry has written to Union Health Minister J P Nadda setting out its objections. Its central complaint is one of category. The draft, the letter says, continues to treat medical devices as an adjunct to pharmaceuticals despite clear scientific, engineering and regulatory distinctions between the two, and so does not provide the regulatory foundation the sector needs to grow, innovate and compete globally.

That objection runs through the specifics. The association opposes applying pharmaceutical vocabulary such as spurious and misbranded to devices, and points out that the draft omits concepts particular to devices, among them biocompatibility, usability engineering and software lifecycle safety. It also notes there is no separate regulatory body staffed with engineers to oversee devices.

The sharper dispute is over criminal liability. The industry body says the bill criminalises administrative and technical lapses in a way that is internationally unprecedented, and that this runs directly against the Jan Vishwas Bill, which decriminalised many minor lapses in order to encourage industry and improve ease of doing business.

The examples are specific. The bill criminalises misleading or wrong information with imprisonment of two years, which would also cover unintentional errors such as clerical mistakes, errors in software-generated data, or mistakes in reporting post-marketing surveillance data. In the case of devices, misbranding could mean a wrong font size, an incorrect symbol, a software version mismatch or a packaging inconsistency.

The draft also expands the powers of inspectors. Beyond what the current Act allows, it permits an official with prior approval to direct the immediate cessation of a specified activity until there is satisfactory compliance, and to arrest a person if a Drugs Inspector has reason to believe that person has committed, is committing, or is about to commit an offence relating to adulterated or spurious drugs. The association describes these as police-style powers.

On process, industry figures say more than 30 suggestions were sent and not one was accepted. The ministry's position is that consultations were held in 2022 and 2023 and that thousands of comments were reviewed. One industry expert responded that reviewing changes makes no difference if none are accepted, and asked whether minutes could be produced showing where concerns were recorded and then incorporated.

The association has asked for a separate medical devices act aligned with global frameworks such as the European Union's Medical Device Regulation or the United States device framework, neither of which criminalises such offences. It has also asked for a new drafting committee including engineering experts, clinicians, biomedical specialists, industry representatives and patient safety groups, kept separate from the drug regulator, arguing that the regulator is currently granting itself extraordinary powers by drafting the bill itself.