If the pandemic, its two waves and unending variants with their sub-lineages have left quite a few in discomfort, the spreading plague of unethical human behaviour and fraudulent business enterprise practices has left quite a few unnerved more than the previous 18 months. From fake vaccination camps, spurious Covid-19 drugs (favipiravir tablets, amphotericin B vials for instance) to adverse events for the duration of clinical trials for vaccines, poor high-quality of testing kits and quite a few more. These required a repair 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 inside India, the spotlight is on the DCGI (Drug Controller General of India), which has been granting licenses to make and sell vaccines, drugs and health-related devices. Its remit just after all, as the central drug regulator, is also to guarantee item high-quality till it reaches the finish customer top quite a few to ask prickly inquiries on what it has been carrying out with its network of drug inspectors.
Proactive Policing
Conversation with several stakeholders, such as these at the level of some states, recommend that the DCGI has been located wanting in terms of taking proactive measures to guarantee high-quality handle and on enforcement. A senior official of a top state drug handle workplace, who did not want to be identified, mentioned, “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 industry for drugs and health-related gear performed 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 items worth a number of crores and hitting out at what had turn into a hub for spurious drugs and improperly stored vaccines. Other than this, some even point to the enthusiasm with which raids had been performed a couple of years ago on manufacture and sales of fixed dose mixture drugs. There are no clear estimates of the actual quantity of raids performed independently by the drug controller but some estimates by sources inside the market and the regulatory method, point to at least about 30 to 50 raids usually in a year. It is arguably a little quantity for India’s size but at least they had been targeting distinctive sorts of fraudulent activities, some thing that does not look to be the case more than the previous year or so when the Covid-19 waves walloped the nation and the loot of Covid patients was taking new types each and every day. Even in terms of enforcement measures taken at the state level, the functionality has been mixed with only some standing out like say these in Gujarat, Maharashtra, Karnataka, Goa and a couple of other folks only.
Questions are also getting asked on what has occurred to the intelligence cell that the CDSCO (Central Drugs Standard Control Organisation) headed by the DCGI set up with significantly fanfare in 2018 with an apparent aim to track illegal activities in the pharmaceutical market?
Talk to sources in the central drug regulatory set up and the arguments are that these are normally seen as the duty at the state level and as a result the reliance is today more on inputs from the states in such matters.
Inspectors & Injections
All of these is in spite of the CDSCO possessing 280-odd inspectors, more than 80 assistant drug inspectors, more than 50 assistant drug controllers and about 30 deputy drug controllers supported by superior quantity of officers in the state governments today. All adding up to about about 2500 individuals. Yes, it may well look little for a nation of India’s size, which may well will need, at least 5 occasions this quantity, going by what some have been feeling internally in the organization.
To what extent is the central drug regulator in search of information and producing its proactive presence felt with some random verify and sending material to the several ICMR (Indian Council of Medical Research) laboratories it is equipped with to test these? Not significantly is recognized although quite a few with the regulatory framework and outdoors do not see significantly activity in this region. Instead, quite a few inside the method complain that the response is located wanting in most instances and wherever there is an action, it tends to be more reactive than proactive. Adding to these is the be concerned about how the central drug inspectors are deployed with quite a few possessing to invest time conducting surveys on drug availability than on checking fraudulent practices and registering instances against the culprits.
Take the investigations into alleged fake vaccination camps that occurred not too long ago in Mumbai, although it is for the neighborhood authorities to look into this and the investigation are on at the neighborhood level by the BMC (BrihanMumbai Municipal Corporation), there are bigger inquiries on security and potency of the vaccines, that the DCGI desires to be worried about. For instance, it may well want to know if the vaccines had been stored at the suitable temperature or whether or not these administered had been expired jabs? Nothing has been heard so far on the Indian drug regulator drawing samples for testing of the vaccine or investigating and searching at identification of the culprits in this case.
Drawing of vaccine samples from the field and monitoring, are also important to verify if there is any deviation in the samples that are sent by a manufacturer to the government laboratory and these that are getting sent out into the industry? Little is recognized on the extent to which this is getting accomplished.
New Approvals But Known Pathways
At a bigger level, the drug regulator desires to address some basic challenges with the Indian drug regulatory method. Unlike say the drug regulator in United States, the US Food and Drug Administration (USFDA), the history of the Indian drug regulator is not definitely about regulating new drugs innovated out of India. There may well be some but these are couple of and far involving and the bigger focus tends to be more about regulating drugs / items that had been created outdoors India with a clear regulatory pathway that only desires to be followed. This signifies, the focus has traditionally been not significantly on clinical details (clinical trials, clinical evaluation, and efficacy and regulations relating to public well being). Instead, the emphasis required to be basically about details on manufacturing and on high-quality of medicine. This is altering now with vaccines as India comes up with newer crop of vaccine development and this signifies a rapid studying in new expertise 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 leading vaccine scientist and professor at the Christian Medical College, Vellore on the way the DCGI is playing its function in investigating drug/ vaccine high-quality and their security 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 important query of making certain high-quality and security, 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 really 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 challenge, 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 instance, 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 rather basic 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 spending 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 worldwide operations (Source: USFDA).
– In India, the annual spending budget for India for drug handle is just in the area of about Rs 150 crore for central drug handle and about Rs 520 crore such as centre and states. (Source: A report by the Comptroller &amp Auditor General of India (CAG) for 2018-19).
– India’s will need: Given India’s size, insiders inside the regulatory method have been in favour of at least 30 to 40 per cent larger spending budget backed by a 5-fold jump in total manpower strength.
– Why evaluate: The USFDA has been in the spotlight as well for the manner in which it has authorized some of the drugs in the current previous and for the duration of the pandemic (assume Hydroxychroloquine for Covid-19 to the Alzheimer’s drug more not too long ago) but it does arguably have a structure that could be important to keep away from any conflict of interest and a method that has the resource backing that enforcement activities demand.