Medical Device Industry and Drug Makers Call for Reform as Controversial Drugs Bill Faces Scrutiny

Medical device and drugs | Photo courtesy: Special arrangement

The eagerly anticipated Drugs, Medical Devices, and Cosmetics Bill, 2023 failed to make its way to the table during the monsoon session of Parliament. This bill was poised to be a transformative step, set to replace the antiquated Drugs and Cosmetics Act of 1940, a relic of colonial times. While the government's intent to modernise regulations in this critical sector is commendable, there is an undeniable cloud of concern shrouding the draft of this Bill, which has been made accessible to the public.

Read More: Neglected Public Healthcare Centres in Gautam Buddh Nagar In Uttar Pradesh Exposed

The current draft is riddled with an alarming number of loopholes, raising serious doubts about its efficacy and impact. Stakeholders within the medical device manufacturing and pharmaceutical industries have joined their voices urging the government to reconsider this legislation. They argue that the Bill, in its present form, falls woefully short of aligning with contemporary needs and demands, putting both the industry and public health at risk.

Rajiv Nath, Forum Coordinator of the Association of Indian Medical Device Industry (AIMED) speaks to The Probe's Rageshree Sengupta

As Rajiv Nath, the Forum Coordinator of the Association of Indian Medical Device Industry (AIMED) explains, "UK, Canada, Brazil, Japan, and even a country like Saudi Arabia have brought in a separate law for medical devices. Medical devices are different from drugs. We are not like a homogenous liquid or a homogeneous chemical. It’s typically an assembly of components to make equipment. Medical devices are currently called drugs in India under the drugs Act. This was a compromise we had agreed to on a temporary basis on an assurance that soon we would get a separate regulatory framework." This compromise, while well-intentioned, has resulted in a regulatory conundrum where medical devices are inaccurately classified, causing confusion and inefficiencies in the industry.

Read More: From Manipur to Rajasthan, Delhi to West Bengal: Women Stripped and Paraded as Society Watches On

Nath argues that the need for auditors and regulators with specialised knowledge in engineering and science is crucial to ensure that medical device manufacturers are held to appropriate standards. "We are not pharmaceuticals. You cannot call an X-Ray machine or any other medical equipment a drug. These are engineering products. What we are seeking is a comprehensive Bill and an audit system that will ensure that we are disciplined and good market surveillance to ensure that unsafe products do not come into the market and this has to be done in an atmosphere where you are not threatening manufacturers. We need a reasonable and implementable law which can be easily understood by engineers and scientists. We don’t want this to be too complicated. What we want is that people who are auditing should not be medical officers. This is like asking the police officer to do the army officer’s work. These are two different areas and it needs completely different skillsets”.

While Nath's call for the new drugs Bill revolves around patient safety, access to safe medical devices, and the promotion of domestic manufacturing, another paramount concern looms large—transparency. Senior lawyer Ashwin Sapra, Partner and Head of Pharma and Healthcare at Cyril Amarchand Mangaldas, raises a crucial point regarding the transparency and effectiveness of the proposed legislation.

Sapra states: “When you bring in such a new regulation, you need to engage with all the stakeholders. You cannot just bring in a regulation devised by people who really don't understand the industry. There should have been inclusive dialogue and collaboration between regulators, industry experts, and stakeholders so that the Bill is not hollow and serves the interests of all parties involved.”

Sapra argues that the Bill must balance a lot of factors that are essential to foster an environment that encourages innovation, manufacturing, and investment while maintaining stringent quality standards. "We only know about the contents of the 2022 draft version of The New Drugs, Medical Devices, and Cosmetics Bill. That draft Bill itself is not very great. Nothing major has been introduced. We need more robust drug approval and drug recall provisions. We need a separate enactment in case of medical devices as they are still being regulated as drugs. Plus our regulations cannot be so restrictive that nobody wants to manufacture any drugs in India. We must strike a good balance.”

Read More: Probing Medical Negligence Claims in Amit Kataria’s Death

The concerns surrounding the proposed Drugs, Medical Devices, and Cosmetics Bill of 2023 have been met with a chorus of voices decrying its potential repercussions, particularly in relation to domestic players and patient interests. Dr. Viranchi Shah, the National President of the Indian Drug Manufacturing Association, lent his perspective to this ongoing debate, shedding light on the critical importance of striking a balance that safeguards human lives while fostering a competitive industry.

Dr. Shah underscores, "The drug industry is an industry that touches human lives. We touch the lives of millions of people. As a nation, our quest for affordable quality medicines should be of prime importance. In this broad context, we need strong regulation. The new Bill that comes into effect should focus on quality, efficacy and safety."

Dr. Shah also points out the need for updating the existing Good Manufacturing Practices (GMP) guidelines, "Globally Good Manufacturing Practices are important for manufacturing. Globally basic GMP comes as a part of law, and then the detailed requirements come as part of guidelines. The GMP schedule that we have in India is more than a decade old. We want the guidelines to be more current so that they are good for the current times. Plus in the current bill, the manufacturers are criminally liable. Even small failures will face severe consequences. We have requested the government to treat minor offences through corrective measures and not go for extreme steps. There should be grading of offences. For serious offences, punishment should be very severe but for minor mistakes, the punishment should be given accordingly."

One of the notable provisions in the latest version of the draft Bill pertains to the regulation, restriction, or potential ban on the online sale of prescription drugs. This development has stirred discussions and elicited responses from various stakeholders.

Rajiv Singhal, the General Secretary of the All India Organisation of Chemists and Druggists (AIOCD), states that there is a need for clarity in the realm of online pharmaceutical sales. He says, "First thing is it is still not very clear what the latest version of the new Bill encompasses. But having said that, I want to say that the drugs have to be delivered in the presence of a registered pharmacist. There are a lot of online pharmacists who are indulging in malpractices, and we really need a strong rule that will regulate these e-pharmacists. We have given many suggestions to the government. We are yet to see the final contours of the new drugs bill."

To ACCESS and SUPPORT our exclusive stories and impactful public interest journalism, subscribe to our YouTube channel. Click on THE PROBE'S LOGO below to subscribe.