Posing grave risks for patients

In the past few months, several Indian drug companies have been hauled up by the United States Food and Drug Administration (USFDA) for not following quality standards for drugs they export to America.

Exports from as many as four facilities of Ranbaxy have been restricted. Previously, the same company had to cough up a penalty of $500 million for supplying adulterated drugs to American consumers.

Another major supplier, Sun Pharma, too has been restrained from exporting drugs manufactured at one of its plants in Gujarat. Wockhardt has faced similar action against two of its manufacturing units in India, while Dr Reddy’s Lab voluntarily recalled 58,000 bottles of a heartburn drug due to microbial contamination. Indian drug companies have been found guilty of charges ranging from violating standard manufacturing practices to fudging quality-related data.

Such actions by the American drug regulator, with an intention to protect the safety of its patients, are to be seen in the context of the fact that India is one of the major suppliers of generic drugs to America. For the Indian industry, therefore, such actions are of far-reaching implication and could potentially hurt its commercial interests. Indian companies export drugs worth $15 billion every year and America is the largest target country. There are about 360 USFDA approved drug manufacturing units in the country. That’s why the industry wants the government to intervene and take measures for damage control. It is also being speculated that the US action may have something to do with recent patent-related decisions in India such as issue of compulsory licenses for cancer drugs, which hurt the interests of American companies.

The USFDA action, however, poses another set of important questions, which not many are willing to discuss. First and foremost, it raises serious doubts about the effectiveness of India’s own regulatory system. The quality, safety and efficacy of drugs are supposed to be governed by a two-tier regulatory system — the Central Drugs Standard Control Organization (CDSCO) at the central level and Drug Control Departments at state level, with both working under the provisions the Drugs and Cosmetics Act, 1940. The regulatory mechanism also covers quality, safety and efficacy of medical devices and clinical trials. To say the least, regulation has not kept pace with the growth of this sector. Senior positions are not occupied by qualified staff and many posts are vacant. Advisory panels are infiltrated by industry, as noted in the report of the parliamentary standing committee two years ago. The result of all this is lax regulation. This is perhaps the reason a foreign regulator like USFDA deems it necessary to come to India and inspect manufacturing facilities so that the interests of its own consumers are protected.

It is only when the USFDA inspects our factories that we come to know about the abysmal state of affairs in drug manufacturing in our backyard. The inspection reports available on the website of the American regulator show how unqualified staff handles test samples, how tests are repeated until ‘right’ results are obtained, how datasets are overwritten and non-conforming samples are destroyed. If this is the state of affairs in manufacturing units which are supposed to maintain high standards as they are catering to export markets, then one can imagine what happens in units that make drugs for domestic markets. We do not know of any routine quality inspections done by Indian regulators on companies which have been inspected by USFDA. If they have been inspected, those reports are not available in public domain. CDSCO occasionally carries out surveillance drives at manufacturing units. Forget making inspection reports public, the regulator does not even tell consumers names of companies inspected or drugs found to be ‘not of standard quality’. We also don’t know if any action is taken against such companies. In such a situation, how will the Indian regulatory system be considered credible, at least in the eyes of the patient? Does it mean that a manufacturing unit which is found to be of inferior quality or standard for American patients is okay for poor Indians?

Companies which recall huge quantities of drugs from foreign markets continue to sell the same drugs in Indian markets. It is the fear of regulation that makes them adopt such double standards. The penalties for compromised quality in some markets are so high that companies are ready to take voluntary action. Here in India penalties are unheard of, so why bother about a lapse here or a failed quality test there.

Unless the Indian regulator gets tough like USFDA and starts naming and shaming defaulters besides levying hefty penalties, Indian firms will continue to flout regulations. But before it does so, the regulator will have to set its own house in order both at the central level and in the states.

It was in 2003 that the Mashelkar committee had given a blueprint for developing a robust and professional drug regulation system. It has been more than a decade but nothing has been done to implement even one recommendation. The last we have heard on this is a proposal from the health ministry to set up a Central Drugs Authority (instead of an independent Central Drugs Administration suggested by Mashelkar panel) headed by secretary of the health ministry and having half a dozen other secretaries as ex-officio members. Given the recent episode of an upright health secretary getting sacked summarily, one can imagine what will be the fate of such a drug regulator. This only goes to show that the health ministry wants to keep the drug regulator under its thumb, and that the government is not serious at all about effective and transparent drug regulation. In any case, the drug regulator should change its outlook. The focus of regulation should be patient safety and not drug exports. All steps necessary to protect Indian patients — be it clinical trials or quality of drugs in the market — must be taken on a priority basis.

The writer is a journalist and author based in New Delhi