The drugs regulator is sick

In the week that Parliament adjourned over a cartoon, a report had been placed in the Rajya Sabha.

A stinging report on the working of the drug regulator's office — the gateway for all medicines made, marketed and consumed in the country.

There were, however, no shrill voices of concern among policy-makers on the report's alarming observations on the Central Drugs Standard Control Organisation (CDSCO) — the agency that implements drug regulations in the country. But this seeming indifference was more than made up for by the well-researched report of the Parliamentary Standing Committee that delivered its punch from the start.

The very mission of the CDSCO is “skewed”, the report said, as it aims to meet the aspirations, demands and requirements of the pharmaceutical industry.

A stark contrast from the stated mission of the United States Food and Drug Administration (USFDA), that seeks to protect “public health by assuring the safety, efficacy, and security of human and veterinary drugs.” Or the UK's regulator, The Medicine and Healthcare Regulatory Authority's (MHRA) mission: “to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe.”

The biggest stakeholder, the consumer, has been neglected, the report said, even suggesting that the CDSCO recast its mission statement to convey in no unambiguous terms that it is about public health.

Over-burdened

From understaffing and not having the infrastructure or expertise to deal with new drug approvals, to actually colluding with the drug industry to short-cut trials and drug approval times — the report nails the regulator's problems.

The Drugs Controller General of India (DCGI) heads the CDSCO. And between 2005 and 2009, an average of about 1,600 applications of new drug categories, including biologicals were received annually.

The work involving approvals of these medicines was handled by 25 regular staff assisted by 25 contractual technical staff, the report noted.

At the headquarters, there were four Deputy Drugs Controllers and five Assistant Drugs Controllers. And these nine officers handled each year approximately 20,000 applications, over 200 meetings, attending to 11,000 public/industry representatives, responding to 700 parliament questions, around 150 court cases, and so on. It does not end there. They also needed to attend several Health-Ministry related committee meetings; provide inputs for amendments to the Drugs and Cosmetics Act, build pharmaco-vigilance programmes, among other things. Not surprising then, these officers were both “overburdened and overstretched,” the report observes. Of 327 posts sanctioned, 124 were filled up to October, 2011. And work was in progress for over 203 vacant posts in CDSCO — joint/deputy/assistant drug controllers, drug inspectors.

The CDSCO's workload increased at about 20 per cent per year, compared with the pharma industry's growth of over 10 per cent. But there was no corresponding increase in manpower and infrastructure to tackle this demand, the report observed.

Under-qualified

Staffing the regulator is one thing, but the chief's own qualification is quite another concern.

Comparing the post of the DCGI with the heads of other regulatory bodies, the report observed that the minimum prescribed academic qualifications for the DCGI was B. Pharm. The top job also required experience in manufacture or testing of drugs, or enforcement of the Drugs and Cosmetic Act for five years. Further, it stipulated that the post-graduation be either in pharmacology or microbiology, excluding post-graduates, even doctorates, in a clinical subject.

“Highly qualified medical doctors may be reluctant to work under and report to a higher officer with lesser qualifications in a technology-driven regulatory authority set-up,” the report said. Contrast this with the Commissioner of the USFDA, an experienced medical doctor, scientist, and public health specialist.

The present Chief Executive of the British MHRA is a professor qualified in medicine from Cambridge and trained in public health.

Calling for a revision of qualifications for the DCGI's post, the report said: “...it is not very rational to give powers to a graduate in pharmacy, who does not have any clinical or research experience, to decide the kinds of drugs that can be prescribed by super specialists in clinical medicine…” The DCGI's post is vacant now, with an official holding temporary charge, the report points out, adding that the time to change and strengthen the office is now.

Invisible hand

The report then puts on record practices that have till now been the stuff of whisper campaigns — alleging that that drug companies colluded with doctors and the drug regulator's office to get medicines approved for sale in the local market.

“Personal perception” rather than “scientific evidence” was evident in opinions given by medical experts on medicines finally marketed in the country, the report says.

Worse, it added, there was adequate evidence to conclude that many opinions were actually written by “invisible hands of drug manufacturers” and experts merely obliged by putting their signatures.

In one case, a CDSCO official advised the manufacturer, Themis Medicare Ltd, to not only select experts but get their opinions and deliver them to the DCGI office!

The report further alleged that drug majors, including Novartis, GlaxoSmithKline, Eli Lilly, Bayer and Cipla, were allowed by the drug regulator to, among other things, cut short clinical trial time on certain medicines, on grounds that they catered to an “unmet medical need”.

Drug companies refute this, saying the DCGI decides on abbreviated trials and medical experts. And global trials on a medicine sometimes include the Indian population, they say, putting to rest fears of Indian ethnicity not being considered.

Be it approving irrational medicine combinations at the State or the parroting of “unmet medical needs” at the Centre, without defining an Indian context to it, the regulatory system needs to mend.

And as the national drugs policy on pricing and medicine access, among other things, is debated, the time is right to address deficiencies in the drug regulatory system, too. Else, this report too will end up gathering dust on a shelf, possibly in Parliament library.

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