The Drugs and Cosmetics (Amendment) Bill, 2013, which was introduced in the Rajya Sabha on August 29, is finally open to comments from the public on wide-ranging legislation that covers the regulation of drugs, cosmetics and medical equipment. This Bill is overdue given the shambles in which the current system finds itself.
What is it?
The core objective of the Bill is to set up a central appellate body in the form of the Central Drug Authority (CDA) to regulate the manufacture, import and export of drugs, medical devices and cosmetics. The CDA will act as an all-embracing body for central and state drug controllers. It will be a 19-member appellate body, headed by the Secretary, Union Ministry of Health.
The CDA will specify regulations and norms for central and state drug licencing authorities and will periodically assess their functioning thus doing away with the current dichotomy between the Centre and states that is now widely-accepted as having failed at regulating effectively.
While the Bill is long overdue, there is scope to improve it in many ways. Here are some.
Remove the greys
The new Bill contains a revised approach to centralised licensing with reference to 17 categories of very critical drugs included in the proposed Third Schedule. These are categories of drugs for which only the Central Licensing Authority is empowered to issue manufacturing licences.
Currently manufacturing licences for these drugs are granted by State Drug Controllers after obtaining approval from the Central Drug Controller. It has been observed that owing to the lack of transparent and accountable structures and processes, actions taken by state drug regulatory authorities have led to several lapses within the system of licensing and monitoring.
While I agree on strong regulation for those 17 categories, it is important that centre-state responsibilities be clarified for all medicines manufactured in India. That is the only way to achieve far-reaching change.
I must congratulate the policy makers and the government for including a chapter on medical devices thus bringing everything from equipment to accessories under one umbrella. This new directive would give much-awaited regulatory protection to patients and make manufacturers and dealers of medical devices accountable.
However, in my view this section has not been conceptually harmonised with global directives and may bring complexity to the system. For instance, the word “effectiveness” in the definition of “investigational medical device” should be replaced with “performance”. Words such as “ornamenting” under the definition of manufacturing need to be clarified. We must ensure that language used in this amended Bill does not become controversial and challenged in a court of law thus insulating criminals who adopt unsafe manufacturing practices at the cost of the patient.
The paper trail
The Bill gives powers to the CDA to recall drugs, cosmetics or devices. However, to ensure a safe and secure supply chain of drugs from the point of manufacture to the point of sale/delivery to the patients, the amendment must harmonise state and central government regulations to facilitate compliance on traceability and recall requirements following open, global and inter-operable standards.
Bar coding and a unique, universal product identification system are not presently provided for in the Indian Drugs and Cosmetics Act as is the practice worldwide. It is time we did that in the amended law for all products including the imported drugs.
The amended law must enable laboratories to access adequate reference standards to keep up with new types of formulations and products made available in the supply chain.
It should provide for a “centralised online data bank” that is updated on a regular basis with information on approved/banned/recalled drugs and capable of being accessed by all state drug control authorities. Such a portal should have features that could be integrated with the portals/data banks set up by other countries to exchange information on such drugs.
Build to succeed
The Bill will create a 19-member overarching body to regulate. While I am happy with the organisational structure, my experience of the past three decades with such regulatory bodies has been neither pleasant nor encouraging. I recommend that a selection committee headed by the Union Minister of Health decide on these 19 members, drawn from all stakeholders including patient groups or organisations that have demonstrated tangible contributions in protecting patient rights. The members must be knowledgeable on the subject and should have demonstrated a high degree of credibility and professionalism in their professional careers.
Once the group is selected, it should be kept far away from any kind of administrative and political interference in its day-to-day working.
The Bill comes a full decade after the government appointed a committee of experts in 2003 representing various stakeholders under R A Mashelkar, the former director general of the Council of Scientific and Industrial Research. I was on that committee. We made several progressive suggestions that would greatly improve drug regulatory oversight.
It was only four years later, however, that the central government introduced the Drugs and Cosmetics (Amendment) Bill, 2007 in the Rajya Sabha. This Bill was referred to the Department-related Parliamentary Standing Committee and has been refined on several occasions based on the recommendations made by the Mashelkar committee. It finally saw the light of day in 2013 when it was cleared by the Union cabinet and tabled in the monsoon session of the Parliament.
There is much store being set by this long-awaited piece of legislation. It must not disappoint.
Bejon Misra is founder, Partnership for Safe Medicines India Initiative, started in 2010. He was a member of the R A Mashelkar Commitee set up by the Indian government in 2003 to review India’s drug regularatory system. He is a leading consumer expert and has been active in policy advocacy for the last 30 years. He has worked with governments on consumer protection policies and consumer education and published several papers and studies on consumer behaviour and perceptions on critical issues concerning heath, safety and quality of service. He can be reached at firstname.lastname@example.org
Pic courtesy Bejon Misra
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