‘Suggestions not accepted’: Bill to overhaul drugs law faces opposition from pharma, medical device sector

The Association has opposed the use of pharmaceutical-related terms such as “spurious” or “misbranded” for the devices; criminalisation of smaller issues such as labelling errors, documentation lapses or engineering defects that cause no harm; no separate regulatory body with engineers to regulate the medical devices.

The organisation, in its letter, states that the draft omits device-specific concepts such as biocompatibility, usability engineering and software lifecycle safety among others — something that puts India behind global regulators when it comes to medical devices.

The Association has also opposed the expanded “police style powers” for the inspectors. In addition to the powers granted by the current Act, the new Bill allows “with prior approval… direct the immediate cessation of the specified activity for a period until satisfactory compliance” and “arrest any person, if Drugs Inspector has reason to believe that such person has committed, is committing, or is about to commit an offence related to adulterated or spurious drugs”. A copy of the Bill has been viewed by the Indian Express.

‘No consultation’

Pharmaceutical and medical device associations have alleged that there was no consultation with the industry while formulating the Bill, which would affect one of the key industries.

“This Bill is almost the same as the one that the government tried to bring to Parliament in 2022 and 2023, but the process was halted after opposition from the industry. It has been revived without any of the changes that the industry had requested,” said a medical device industry expert, on condition of anonymity.

According to the expert, the Bill was sent for inter-ministerial consultation. “The ministry said there were consultations held in 2022-23 and thousands of comments had been received from stakeholders, which had been reviewed. But reviewing the changes makes no difference if none of them are accepted. We had sent more than 30 suggestions and not one has been accepted in the new draft. They have also said that stakeholder consultations were carried out. Then, they should be able to show any minutes of the meeting where our concerns were recorded and then incorporated in the Bill?”

An expert from the pharmaceutical industry said the last consultation on the Bill happened in 2022-23 and the draft mostly remains unchanged since then.

The Association, in its letter to Nadda, asked for the constitution of a new committee with engineering experts, clinicians, biomedical specialists, industry representatives and patient safety groups — “separate from the drug regulator drafting group”. “At present, by drafting the Bill, the drug regulator is granting itself extraordinary powers,” said the first expert.

The body has also asked for structured stakeholder consultation before the finalisation of the Bill.

More powers

The industry body has said that the new Bill criminalises administrative and technical lapses, which is internationally unprecedented. This is in direct contrast to the government’s Jan Vishwas Bill, which has decriminalised many minor lapses included in the current Bill, in order to encourage the industry and ensure ease of doing business.

“I am actually happier with the current law than this draft. Criminalising such minor offences will only lead to more corruption instead of actually improving the quality of products,” said another industry expert.

For example, the Bill criminalises misleading or wrong information with imprisonment of two years. This would also cover unintentional, minor errors such as clerical mistakes, errors in software-generated data, or mistakes in reporting the post-marketing surveillance data.

The Bill also criminalises misbranding, which in the case of devices could mean a wrong font size, incorrect symbol, software version mismatch, or packaging inconsistency. The body has also asked for a separate medical devices act that aligns with the global best practices followed by the EU’s Medical Device Regulation or the US FDA device framework, which does not criminalise such offences.

They have also asked for administrative reforms such as recalls, corrective actions and penalties for technical lapses, and a risk-proportionate penalty, licensing, surveillance, and enforcement framework.