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- Last month, the Union Ministry of Health and Family Welfare published a draft New Drugs, Cosmetics and Medical Devices Bill, 2022 with the aim of replacing the colonial era Drugs and Cosmetics Act, 1940.
- Sadly, the new Bill is almost entirely a copy of the existing law, with a few tweaks.
- Unlike other legislative efforts, the present exercise was not preceded by the creation of a committee of experts or a white paper on the policy imperatives.
Last month, the Union Ministry of Health and Family Welfare published a draft New Drugs, Cosmetics and Medical Devices Bill, 2022 with the aim of replacing the colonial era Drugs and Cosmetics Act, 1940. Sadly, this draft is a far cry from anything resembling a “reform” of the status quo. As obvious from this clause-by-clause comparison that we prepared, the new Bill is almost entirely a copy of the existing law, with a few tweaks. Only the chapter on “medical devices” is new.
Unlike other legislative efforts, such as the one leading to the Personal Data Protection Bill, the present exercise was not preceded by the creation of a committee of experts or a white paper on the policy imperatives. Instead, the health ministry set up a committee of bureaucrats serving within the existing drug regulatory framework. One of these bureaucrats has since been arrested on suspicion of corruption, while the Chairperson of the drafting committee was the incumbent Drug Controller General of India (DCGI) who presided over the chaotic drug approvals during the COVID pandemic.
Most of the new drugs approved by this DCGI for the treatment of COVID-19 were not included by the government’s taskforce in the national treatment guidelines and rightly so, since there was barely any evidence to support the fact that these drugs could treat COVID. Yet since the DCGI had given these drugs its seal of approval, many doctors did prescribe the drugs for COVID to unsuspecting and mostly anxious patients.
The DCGI has been responsible for a wholesale transfer of wealth from the pockets of poor and middle class Indian citizens into the coffers of pharmaceutical companies. By conservative estimates, just one drug, which was approved by the CDSCO based on shoddy clinical data made Rs 762 crore for its manufacturer without it being a part of the Covid-19 National Treatment Guidelines. That the man responsible for these approvals was put in charge of drafting a new law was an invitation for disappointment.
As I have written elsewhere and in comments submitted to the Ministry of Health, the new Bill should have tackled key issues pointed out in the reports of expert committees like the The Mashelkar Committee and The Ranjit Roy Chaudury Committee, as well as committees like the Parliamentary Standing Committee on Health and Family Welfare in its 59th Report reviewing the functioning of the Central Drug Standard Control Organisation (CDSCO). Some of these issues included the question of regulatory federalism, discretion in new drug approvals, misleading claims by Ayush drug manufacturers etc. These are politically knotty issues that cannot be resolved by bureaucrats without political backing from the Minister.
For instance, the federalism issue involves a long running debate on transferring licensing powers from the state drug controllers to a central regulator. This issue involves a tussle between state and central bureaucracies, state political parties who have members with interests in the pharmaceutical industry and the SME (small and medium enterprises) pharmaceutical industry which prefers negotiating with local bureaucrats and politicians. But as I discussed in the comments, there is a strong case to ensure centralising those regulatory functions, like the licensing of manufacturers, which have the potential to affect the entire country.
People in Tamil Nadu and Maharashtra should not have to pay the price for incompetent state drug controllers in Himachal Pradesh (HP) who refuse to investigate or cancel manufacturing licences of companies with woeful manufacturing track records. For example, the company accused of manufacturing the adulterated cough syrup that killed 11 children in Jammu had been flagged on 19 different occasions by state and central government laboratories after its products failed quality testing. Yet no substantive action was taken against the company by the state drug controller in HP.
Similarly, the issue of regulating the Ayush industry requires taking on political giants like Patanjali and Baba Ramdev. The last time the Ministry of Ayush tried to regulate this issue by introducing rules on advertising, the entire Ayush industry sued the government before the Delhi high court. These deep-rooted issues require intervention by the Minister because bureaucrats, given their risk-averse nature are unlikely to take on politically explosive issues.
Apart from the above issues which require political intervention, there is also the question of making the regulator accountable for its actions. In the context of drug regulation which vests a vast amount of discretion in the hands of bureaucrats, the only way to assure such accountability is through transparency. Every aspect of regulation should require publication of data and government records so that doctors and ordinary members of the public can inform themselves of the regulator’s actions. Expecting a committee of bureaucrats to make themselves more accountable through transparency is like expecting criminals to campaign for stronger criminal laws. It is just not going to happen.
One of the key lessons from the COVID-19 pandemic was that even the most competent and well resourced public health institutions were caught short in addressing the needs of their citizens. The Centres For Disease Control and Prevention, a 75-year-old venerable institution with remarkable success publicly acknowledged recently that it will undertake an exercise to fundamentally restructure itself and its operations to make it more nimble and responsive to public health emergencies. It appointed an external expert lead this initiative. Some of the improvements that the director, Dr Walensky envisions from this review will require new authorities from the US Congress. Sadly, this exercise to amend the colonial era law to make it more responsive to the people of India does no such thing.
The sum and substance of my criticism is that a committee of bureaucrats tasked with drafting a new law was always going to disappoint in the absence of clear political direction from the elected minister. One can only hope that the Minister for Health scraps this bill and constitutes a new committee which is given some clear political direction to guide it while drafting a new law.
Dinesh Thakur was the whistleblower in the Ranbaxy case.