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Gireesh Babu, New Delhi March 30 , 2023
While reports quoting health ministry sources claim that licenses of several pharma manufacturing units have been cancelled across the country after joint risk-based inspections by both the Central and the State drug regulatory authorities, public health experts feel that the effort is too late and the regulator needs to be more transparent to reveal the actual inspection reports and the name of the companies.

According to news reports, the joint risk-based inspections across 20 states in the country have resulted in cancellation of licenses of 18 manufacturing companies. This also comes in the backdrop of the concerns raised by various public health experts and even some of the pharma manufacturers regarding the prevalence of not of standard quality medicines in the market.

T Prashant Reddy, a lawyer and co-author of ‘The Truth Pill: The Myth of Drug Regulation in India’, said that the action cannot be seen as a serious effort since what is needed is structural reforms rather than action against individual companies.

“I see it as a cosmetic measure. The name of the companies which lost their license in the process is not being revealed. What about the drugs they have manufactured? Are they recalling them from the market?,” he asked.

“If the regulator is really serious, we need structural reforms. Going after individual companies is helpful only to a certain limited extent. We need structural reforms and the buck stops with the Secretary of Health Department,” he added. The Drug Controller General (India) has the limited power of implementation of law, and since the powers to issue and cancel licenses is with the State Licensing Authorities, which are controlled by state governments, it has no powers over them as well.

Gopal Dabade, coordinator of All India Drug Action Network (AIDAN), while welcoming the action by the regulators, said that the processes involved in these actions should be revealed.

The inspections have to be done in a holistic manner, taking various parameters including the background and track records of the companies which are being inspected into consideration.

“Sometimes I wonder whether our regulatory authorities are trained in such a level also. Picking up drug samples from some companies and testing and penalising them is not enough. Even the legal process is very cumbersome even if a company has been identified as manufacturing spurious or substandard drugs,” he added.

“The regulatory activity should be uniform across the States and this is where things are lacking. It is important that the inspection and testing methodology across the country should be uniform, adequate and well-equipped. The inspectors should be trained to look at various aspects of the inspection,” added Dabade.

Commenting on the reports, a regulatory expert said that the action is too late considering that the reputation of the Indian manufacturers has been impacted by various incidents since last year.

“Something is better than nothing, but it is late. Especially, if you look at the current situation where the quality concerns over the medicines manufactured in the country have been going on for several months now and the regulator is responding after these many months, it is too late,” said the expert. It is also important that the regulator should be transparent and reveal the names of the companies on which action has been taken following the joint inspection.

It may also be noted that the claims on cancelling of licenses based on the inspection are yet to be declared officially by the government. Many of the state drug regulators are also tightening their monitoring activities, apart from the joint efforts with the CDSCO, said regulatory sources.

According to a senior official from the Government of Himachal Pradesh, the state drug regulator and the CDSCO jointly inspected around 30 units under the risk based inspection, and out of those, in seven cases it has issued stop manufacturing orders. Of this, in six cases, the manufacturer complied with the observations made by the joint inspection team and after verification, the orders were revoked. But in one case, the manufacturer is still complying to the observations made by the regulator.

Inspections are a continuous process and the state regulator keeps on inspecting on its own and also jointly with the CDSCO. For the last three years, the State regulator has issued stop manufacturing orders or suspension orders in more than 43 cases in Himachal Pradesh. Under the risk based approach, joint inspections were conducted on companies whose samples have failed repeatedly.

Reddy said that his book suggested some very doable reforms to address the issues related to regulatory implementation, starting with making transparency the cornerstone of regulation.

“The drug regulator doesn't publish inspection reports or test reports properly, nothing in a searchable database, which should be accessible to the public. This can be done overnight. The more complicated reforms required include centralisation of drug regulation, because the state level politics is corrupting drug regulation. Another long pending reform is to separate CDSCO and give it its own corporate structure, like SEBI and TRAI,” he added.

While the government committees itself has recommended such an upgradation and spin off and the amendment bill in 2013 had this as one of the suggestions, the draft New Drugs, Medical Devices and Cosmetics Bill, 2022 has not looked at even the government committee recommendations, alleged Reddy.

Dabade said that there should be a scientific approach for selecting the drug samples, assessment of the drug company should be done on a regular basis, so that the drug company should also be alert on any mistakes they could commit which will come up during such inspections.

“We need to learn from the likes of the US Food and Drug Administration (FDA) on how the inspections and assessments are conducted. The Indian drug regulator should be open to learning things from other countries. There are some things that need to be followed and that need to be deep rooted,” he added.

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