It’s time India’s drug controller confronts key questions on quality control & enforcement

If the pandemic, its two waves and unending variants with their sub-lineages have left many in pain, the spreading plague of unethical human behaviour and fraudulent business practices has left many unnerved over the past 18 months. From fake vaccination camps, spurious Covid-19 drugs (favipiravir tablets, amphotericin B vials for instance) to adverse events during clinical trials for vaccines, poor quality of testing kits and many more. These needed a fix by the regulators with stern corrective measures but the achievement on this front has been underwhelming.

While a lot of drug regulation activity has to be handled at level of states within India, the spotlight is on the DCGI (Drug Controller General of India), which has been granting licenses to make and sell vaccines, drugs and medical devices. Its remit after all, as the central drug regulator, is also to ensure product quality till it reaches the end consumer leading many to ask prickly questions on what it has been doing with its network of drug inspectors.

Proactive Policing

Conversation with various stakeholders, including those at the level of some states, suggest that the DCGI has been found wanting in terms of taking proactive measures to ensure quality control and on enforcement. A senior official of a leading state drug control office, who did not wish to be identified, said, “please remember the grant of licenses and approvals that tends to be in the news during the pandemic, is still an obligatory service, the real challenge lies in enforcement and prosecuting the culprits under the Drugs and Cosmetics Act, tracking spurious drugs and filing such cases in the court of law.” He says, “the field officers and inspectors of the DCGI working across different states have hardly been filing any cases against wrong-doers, at least over the past few months.”

Which is why, they say, we no more hear of the stories like the raids on Delhi’s Bhagirath Palace, a wholesale market for drugs and medical equipment conducted by the drug controller a couple of years ago or in 2017 to be precise. Back then, in the pre-pandemic days, it ended up confiscating products worth several crores and hitting out at what had become a hub for spurious drugs and improperly stored vaccines. Other than this, some even point to the enthusiasm with which raids were conducted a couple of years ago on manufacture and sales of fixed dose combination drugs. There are no clear estimates of the actual number of raids conducted independently by the drug controller but some estimates by sources within the industry and the regulatory system, point to at least around 30 to 50 raids typically in a year. It is arguably a small number for India’s size but at least they were targeting different kinds of fraudulent activities, something that does not seem to be the case over the past year or so when the Covid-19 waves walloped the country and the loot of Covid patients was taking new forms each day. Even in terms of enforcement measures taken at the state level, the performance has been mixed with only some standing out like say those in Gujarat, Maharashtra, Karnataka, Goa and a few others only.

Questions are also being asked on what has happened to the intelligence cell that the CDSCO (Central Drugs Standard Control Organisation) headed by the DCGI set up with much fanfare in 2018 with an apparent aim to track illegal activities in the pharmaceutical industry?

Talk to sources in the central drug regulatory set up and the arguments are that these are often seen as the responsibility at the state level and therefore the reliance is today more on inputs from the states in such matters.

Inspectors & Injections

All of these is despite the CDSCO having 280-odd inspectors, over 80 assistant drug inspectors, more than 50 assistant drug controllers and about 30 deputy drug controllers supported by good number of officers in the state governments today. All adding up to about around 2500 people. Yes, it may seem small for a country of India’s size, which may need, at least five times this number, going by what some have been feeling internally in the organization.

To what extent is the central drug regulator seeking data and making its proactive presence felt with some random check and sending material to the various ICMR (Indian Council of Medical Research) laboratories it is equipped with to test these? Not much is known though many with the regulatory framework and outside do not see much activity in this area. Instead, many within the system complain that the response is found wanting in most cases and wherever there is an action, it tends to be more reactive than proactive. Adding to these is the worry around how the central drug inspectors are deployed with many having to spend time conducting surveys on drug availability than on checking fraudulent practices and registering cases against the culprits.

Take the investigations into alleged fake vaccination camps that happened recently in Mumbai, while it is for the local authorities to look into this and the investigation are on at the local level by the BMC (BrihanMumbai Municipal Corporation), there are larger questions on safety and potency of the vaccines, that the DCGI needs to be worried about. For instance, it may want to know if the vaccines were stored at the right temperature or whether those administered were expired jabs? Nothing has been heard so far on the Indian drug regulator drawing samples for testing of the vaccine or investigating and looking at identification of the culprits in this case.

Drawing of vaccine samples from the field and monitoring, are also crucial to check if there is any deviation in the samples that are sent by a manufacturer to the government laboratory and those that are being sent out into the market? Little is known on the extent to which this is being done.

New Approvals But Known Pathways

At a larger level, the drug regulator needs to address some fundamental challenges with the Indian drug regulatory system. Unlike say the drug regulator in United States, the US Food and Drug Administration (USFDA), the history of the Indian drug regulator is not really about regulating new drugs innovated out of India. There may be some but these are few and far between and the larger focus tends to be more about regulating drugs / products that were developed outside India with a clear regulatory pathway that only needs to be followed. This means, the focus has traditionally been not much on clinical information (clinical trials, clinical evaluation, and efficacy and regulations relating to public health). Instead, the emphasis needed to be essentially around information on manufacturing and on quality of medicine. This is changing now with vaccines as India comes up with newer crop of vaccine development and this means a quick learning in new skills and newer practices such as emergency use authorisation, restricted use and administration in a clinical trial mode, tasks and terms new for the Indian regulator also.

Monitoring & Reporting

Ask Dr Gagandeep Kang, India’s top vaccine scientist and professor at the Christian Medical College, Vellore on the way the DCGI is playing its role in investigating drug/ vaccine quality and their safety and she says: “I am very pleased that the DCGI had issued a guidance in September 2020 on how the vaccines for covid-19 will be approved and the data that would be required for granting the approvals. But then, the DCGI sadly did not follow its own guidelines in January this year. Now, I do hope for the future, the DCGI will also begin publishing and following its own recommendations on how the multiple vaccines in the pipeline will get approved.” On the crucial question of ensuring quality and safety, she feels, “it will all depend on the how much of post marketing studies are being sought by the DCGI. As of now, there is little clarity on this.” But she does feel, it is time “the regulatory system is improved to ensure there is better reporting of product monitoring and quality, aspects on which information made available is still all very sketchy.”

Duties Defined, Roles Reworked

Veteran virologist Dr Shahid Jameel, who is also the director of the Trivedi School of Biosciences at Ashoka University says, “like the regulators in USA and Europe, there has always been a need to have more transparency on the profile of the experts on the Indian drug/ vaccine approving panel.” Partly, the problem, he says, “is also built into the structure of regulation in the country where the drug regulator, is not quite like a USFDA. There is a need to empower the regulator with trained manpower to handle surprise checks. The larger problem in the Indian context is that the roles have to be clearly defined. This is crucial to ensure greater accountability and transparency, which is missing at the moment.” For example, he says, “we found a research organization (the ICMR) managing the pandemic, when it’s job is to develop the best tools and carry out timely surveillance. Good serosurveys for India are still missing.”

TABLE: The Empowering Imperative – a comparison with the US

The challenge facing the Indian drug regulator is also quite fundamental in terms of its structure, clout and independence:

– Independence:

– In the US, the commissioner of the US Food and Drug Administration (USFDA) enjoys a considerable clout and authority as an independent regulator.

– In India, the DCGI holds the rank of a joint secretary.

– Budget:

– In the US, the annual budget for the USFDA is $ 5.9 billion (FY 2020) with 33 per cent for human drugs. While, it could be argued that it has global operations (Source: USFDA).

– In India, the annual budget for India for drug control is just in the region of around Rs 150 crore for central drug control and about Rs 520 crore including centre and states. (Source: A report by the Comptroller & Auditor General of India (CAG) for 2018-19).

– India’s need: Given India’s size, insiders within the regulatory system have been in favour of at least 30 to 40 per cent higher budget backed by a five-fold jump in total manpower strength.

– Why compare: The USFDA has been in the spotlight too for the manner in which it has approved some of the drugs in the recent past and during the pandemic (think Hydroxychroloquine for Covid-19 to the Alzheimer’s drug more recently) but it does arguably have a structure that could be crucial to avoid any conflict of interest and a system that has the resource backing that enforcement activities require.