Metamorphosis of a watchdog

From finding worms in chocolates and revealing the truth on baby oils to putting the spotlight on online pharmacies, the Maharashtra Food and Drug Administration has found itself at the eye of many a public health storm.

But FDA Commissioner Harshadeep Kamble envisions a role for the regulator beyond wielding the stick on errant companies, as a “facilitator”, equipped to train officers and industry.

The Commissioner has just finished a review of the working of his office and proposed to the State government an overhaul that involves “tripling” the number of hands on deck and strengthening the laboratory infrastructure. But an initiative he is keen to get on the road is to expand the Maharasthra FDA’s role as a research and training institute.

“Our job is not to shut down businesses that we have given licences to,” he says, observing that oftentimes violations are because people are not aware of the law. The Maharashtra FDA is a repository of knowledge on food and drugs, he says, and it can train its own officers in the latest techniques and trends, besides organised and unorganised industry players on the requirements of the law.

An executive council with regulatory and industry experts would oversee this initiative, he says, “without the sword of the regulator”. And importantly, this can be a revenue- generating initiative, he adds. As a regulator, “your role is very different”. The FDA is not a “revenue earning department”, he says, but one that’s involved with public health and safety.

Oftentimes, though, even fulfilling that role involves working against the odds. Since the last review in 1990, Kamble says, work has trebled, from overseeing 25,000 drug manufacturing and selling units to 75,000 today. The number of drug inspectors then was 161. Even today it stands at 161, he says.

The number of food safety officers in Uttar Pradesh is 650 and Tamil Nadu has 580, but Maharashtra has just 260 food safety officers.

And in this period since the last review, food business operators have increased from one lakh to nine lakh (including small registered businesses), he says, doling out the numbers almost clinically, but telling the appalling story of shortfall. “Work has gone up nine-fold but I have the same number of officers, he says.

The Hathi Committee and Mashelkar’s suggestions were to increase drug inspectors to 934 and 450 respectively, he says, of recommendations made decades ago.

Tech versus public safety Meanwhile, the FDA’s job has not just gone up in volume, but also in its nature.

Kamble headed a panel that looked into the new phenomenon of online pharmacies. He does not get drawn into discussing its recommendations, except to say that a cautious approach is needed given the long-term impact on health delivery.

Technically speaking, says Kamble, anything that can help is welcome, “but technology should not play with the health and life of consumers.” It is a relatively new area for foreign regulators as well, he says, adding that the guiding principle is that technology comes second to public safety. A direction on this contentious issue is expected from the Centre shortly.

Chemist and retailer associations are against online pharmacies because they say it could give easy access to prescription drugs, especially psychotropic drugs, cough syrups, etc., that can be abused. But e-pharmacy representatives counter that by pointing out that every transaction has an electronic footprint and so in fact, online pharmacies can help curb malpractice.

Responding to the perception of corruption that hovers over the regulatory infrastructure in the country, Kamble says that going online has made the FDA’s workings and decisions transparent. The licensing system, he says, is designed such that an officer has to respond in a month and cannot go to the second application till the first is done. This means an application cannot be prioritised for any reason, he adds.

Even field and lab reports are online, he says, of systems that will be tested when the next health concern involving noodles, talcum powder, cough syrups and more, lands at the FDA’s doorstep.

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