India's NSQ drug problem needs a federal regulatory solution

India market

Furious efforts by the Drug Controller General of India (DCGI) to test drugs in the market and inspect and train manufacturers for quality will fall flat without a unified federal regulatory system.

That's the conclusion of a detailed look by Caravan, a longform journal in India that covers politics and culture, at the country's fragmented drug regulatory system given to sound and fury at the federal level and the reality of implementation handled at the state level.

"India’s pharmaceutical drug regulation system is fractured," author Kaushal Shroff writes, complaining about a lack of penalties for manufacturers of so-called NSQ ("not of standard quality”) drugs.

"Drug monitoring in the country is sparse; it is split between far too many agencies--36 independent state regulators, and one central. Yet, the country lacks a cohesive policy governing the procurement and recall of drugs. The reasons behind this fragmented system are many. For one, under the seventh schedule of the constitution, public health, sanitation, hospitals and dispensaries are listed as matters on which state governments are allowed to legislate. This allows them to develop their own regulatory policy and to not be held accountable by any central body."

The DCGI is currently leading a massive inspection effort of 500 drug manufacturing plants in India aimed at enforcing good manufacturing practice and rooting out repeat offenders.

It has also made efforts to adopt a national barcode system to track drugs domestically, though progress has been slow even as exporters are required to use such labels for shipments to markets such as the U.S. and Europe.

But as a spate of reports have shown, manufacturing quality repeatedly comes up short on data records and sanitary issues even by the country's top drugmakers--such as Sun Pharmaceutical Industries. Dozens of Indian firms and several CROs that test drugs approved for export have been hauled up by European and U.S. regulators with bans on exports that have hurt sales.

At the same time, public interest lawsuits in India are questioning the extent and impact of domestic drug regulation, Shroff notes. He cited efforts by Dinesh Thakur, a former Ranbaxy employee who turned whistleblower to the U.S. Justice Department on the unethical testing and sales practices of the pharmaceutical company. Thakur's cooperation ultimately led to a $500 million fine.

To that end, he said the answer is to change the regulator system to one centralized at the federal level with broad national powers of enforcement--a rarity in India where the lines between state and federal authority are major constitutional issues.

"The rising number of NSQ drugs indicates that existing policies are failing Indian patients, and must be changed," Shroff said.

"A centralized umbrella law on public procurement of drugs will eliminate variation in practices followed by the states and many government organizations, and bring in much-needed accountability of drug manufacturers. The policy will not only help curb extraneous public expenditure, it can affect the millions who are slowly falling prey to sub-standard drugs."

- here's the article from the Caravan

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