New Delhi: The proposed Drugs, Medical Devices and Cosmetics Bill, 2023, is set to get delayed as the government has decided to constitute a fresh review committee following strong objections from the medical device industry, ThePrint has learnt.
The Union Health & Family Welfare Ministry is drafting the bill in order to replace the Drugs and Cosmetics Act, 1940. The government has pitched the new bill as an improvement upon the existing legislation, and as a means of ensuring quality and transparency in the drugs and medical devices sectors.
Among other things, the bill seeks to bring strict regulations for India’s burgeoning pharma industry. However, it has been criticised by the industry on the grounds that medical devices deserve exclusive legislation dealing with them alone, and that it smacks of ‘inspector raj’ with its provisions for search and seizure from even licensed manufacturers.
“The idea was to get the bill cleared by the Union Cabinet and present it in the recently concluded Parliament session but that could not happen as the medical device industry expressed reservation against the bill,” said a senior official in the ministry.
“We have now decided to form a panel that can look into the concerns being raised by the industry,” the official added.
Rajiv Nath, forum co-ordinator of the Association of Indian Medical Device Industry (AIMED), welcomed the decision, saying that the industry’s views should be counted. The inputs shared by the association earlier, he added, had been completely ignored in the formulation of the bill.
ThePrint tried reaching Union health secretary Sudhansh Pant for his comments by calls but there was no response.
‘Backed by parliamentary committee’
According to Nath, the parliamentary standing committee on health and welfare, in response to a government action-taken report on queries regarding medical devices, had said that instead of drafting a combined legislation for drugs, medical devices and cosmetics, the ministry should appreciate the huge potential of the medical device industry and formulate a separate legislation for the segment.
The standing committee made the observations in its 146th report, which was tabled in the Lok Sabha on 4 August. It said that, “to bring a world-class regulatory framework, give boost to the medical device industry and minimise the dependence on imports, a separate department and separate legislation is required”.
According to Nath, the Drugs, Medical Devices and Cosmetics Bill, 2023, had even revised the definition of manufacturer in a way that it will allow a marketing company to get a manufacturing licence. By doing so, the bill inadvertently proposes to legalise “pseudo manufacturing of low-quality cheaper imports that may affect patient safety”.
He said the bill “discourages investments to manufacture these in India by treating domestic manufacturers as potential criminals”, adding that overseas manufacturers are not required to “go through the same rigour to demonstrate conformity”.
All the efforts put in by the government “will be a big waste if this bill is not recalled and reviewed”, he said.
In a letter written to the government last week, the association had said that India needs to move away from “inspector raj”, where inspectors are empowered for search and seizure with even licensed manufacturers, and treat the latter as criminals with threats of imprisonment for even minor offences.
“A good law needs to be simple, reasonable and implementable and give direction of intent for a progressive aspiring nation with superior effective compliance systems,” it said.
Medical electronic devices are an engineering product like cars and can’t be manufactured or regulated like drugs, the letter added. Medical devices, it said, need to be stored, transported, installed, and maintained, and regularly calibrated to ensure patient safety for the lifecycle of the product.
Talking to ThePrint, Girdhar J. Gyani, director general of the Association of Healthcare Providers, India (AHPI), the largest network of private hospitals, backed the issues raised by the medical-device-makers, saying they should be separated from the drugs law if the country’s indigenous industry has to thrive.
“We are totally in agreement with AIMED on this issue,” he said. The AHPI is among the seven other organisations that are supporting the demand to recall the bill.
(Edited by Sunanda Ranjan)