3 weeks ago
Bill to overhaul drugs law faces medical device sector opposition
In India, there is an old rulebook for medicines and medical machines called the Drugs and Cosmetics Act.
The government wants to update and change that rulebook.
But the people and companies that make medicines and medical machines are not happy about it.
They say the government wrote the new rules without asking them what they think.
They also say the new rules are almost the same as an older version that was stopped before.
Some of the new rules could punish people with jail time for very small mistakes, like typos or wrong label sizes.
The makers of medical machines say machines are not the same as medicines, so they should have their own rulebook and their own experts, such as engineers and doctors, helping to write the rules.
They say other countries do not make small mistakes a crime and want India to follow better examples.
They are asking the government to listen to them before making the new rules final.
A Bill to overhaul the Drugs and Cosmetics Act, 1940, being circulated to stakeholder ministries, faces fierce opposition from India's medical device sector.
The Association of Indian Medical Device Industry has written to Union Health Minister J P Nadda, saying the draft treats medical devices as an adjunct to pharmaceuticals.
Industry bodies allege the Bill was revived without stakeholder consultation and is nearly identical to the 2022 and 2023 versions, with none of the industry's more than 30 suggestions accepted.
The draft criminalises administrative and technical lapses such as labelling errors, documentation mistakes and misbranding, and gives inspectors expanded powers to order cessation of activity and make arrests.
The sector is demanding a separate medical devices act and a committee of engineering, clinical and biomedical experts aligned with EU and US FDA regulatory frameworks.
- Who
- The government of India and Union Health Minister J P Nadda, and pharmaceutical and medical device industry associations led by the Association of Indian Medical Device Industry.
- What
- A Bill to overhaul the Drugs and Cosmetics Act, 1940 that industry bodies say criminalises minor technical lapses and was drafted without stakeholder consultation.
- Where
- India.
- When
- The Bill is currently being circulated to stakeholder ministries; earlier versions were attempted in 2022 and 2023.
- Why
- The industry opposes the Bill because it was revived without incorporating stakeholder suggestions and treats medical devices as an adjunct to pharmaceuticals.
Medical device and pharma industry
Government and drug regulator
Stakeholder consultation
Medical device and pharma industry
The Bill was drafted without industry consultation and is almost the same as the 2022-23 version; none of the more than 30 industry suggestions were accepted.
Government and drug regulator
The ministry said consultations were held in 2022-23 and thousands of stakeholder comments were received and reviewed.
Criminalising minor lapses
Medical device and pharma industry
Criminalising administrative and technical lapses such as labelling errors is internationally unprecedented and contradicts the Jan Vishwas Bill, which decriminalised minor offences.
Government and drug regulator
The Bill brings criminal penalties, including up to two years' imprisonment, for misleading information and misbranding offences.
Regulation of medical devices
Medical device and pharma industry
Medical devices are scientifically and engineering-distinct from drugs and need a separate act, a regulator with engineers, and device-specific concepts like biocompatibility and software lifecycle safety.
Government and drug regulator
The draft continues to regulate medical devices within the Drugs and Cosmetics Act framework as part of the pharmaceutical regulatory system.
Key facts
- Legislation
- Drugs and Cosmetics Act, 1940 (overhaul Bill)
- Current stage
- Circulated to stakeholder ministries for inter-ministerial consultation
- Lead opponent
- Association of Indian Medical Device Industry
- Addressed to
- Union Health Minister J P Nadda
- Industry suggestions
- More than 30 submitted; none accepted per industry claims
- Key penalty cited
- Two years' imprisonment for misleading or wrong information
- Earlier attempts
- 2022 and 2023; halted after industry opposition
- Industry demand
- Separate medical devices act aligned with EU Medical Device Regulation or US FDA device framework
Quotes
Association of Indian Medical Device Industry
Industry group representing India’s medical device manufacturers
“(The Bill)… in its present form, does not provide the regulatory foundation required for India’s medical devices sector to grow, innovate and compete globally… The draft continues to treat medical devices as an adjunct to pharmaceuticals, despite clear scientific, engineering and regulatory distinctions between the two categories,”
indianexpress.com
“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,”
indianexpress.com
Sources
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