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No patient will be comfortable taking a medicine if there are quality concerns linked to the company making the drug, says a doctor with a Mumbai-based hospital.
And that is the rub-off that frequent complaints over quality will have, not just on Ranbaxy and Wockhardt, currently under the lens of the US drug regulator, but also on other, locally based, drug companies.
In addition to casting a shadow of mistrust on local drug makers, non-compliance on quality also ends up providing ammunition to those targeting Indian generic-drug companies. There are several in the lobby-infested pharmaceutical industry.
NO EXCEPTIONs
Providing a perspective on the manufacturing deviations pointed out by the US Food and Drug Administration in India-based companies, Ajaz S. Hussain, a former FDA official and founder of US-based consultancy, Insight, says that when it comes to current Good Manufacturing Practices (cGMP), even the biggest global names are hauled up for deviations.
But hygiene concerns are increasingly coming out of India and the frequency with which data integrity issues are emerging shows there is a problem, he adds.
The manufacturing deviations are largely documentation-related, observes C.M. Gulati, Editor with drug journal MIMS , adding that there is a fundamental difference in the way the US regulator looks at the issue.
The Indian regulator’s approach is to throw out a product that is found to be sub-standard, while the US regulator tries to prevent such a product from getting into the system, he points out.
Hygiene issues
Some observations by the USFDA while inspecting India-based companies Ranbaxy and Wockhardt were related to hygiene. They included unclean washrooms, dirty glassware and what appeared to be a human hair on a tablet.
Quality has to begin in the boardroom and percolate to the people working on the shop-floor. It is not a one-time inspection but a continuous process, says a drug industry representative.
Agreeing that companies need to shape up, a Ranbaxy supporter, however, points out that while the company has been stopped from sending drugs from its errant plants to the US, the regulator has not asked patients to stop consuming its drugs. This is in contrast to other global players, such as Merck, whose painkiller Vioxx was taken off the shelves globally, because of its links to heart risks. The company ended up forking out huge amounts to settle patient class-action suits.
Explaining the FDA side, Hussain says the US regulator has the huge task of ensuring products are safe for consumers, since the lion’s share comes from outside.
Global scenario
Companies have been recalling products in the US for various reasons, including medicines being of different sizes, wrong labels, glass or microbial contamination, and so on.
Domestic drug industry representatives point out that while India has 42 import alerts on products going into the US, other countries also feature on that list. China has 77 import alerts, Canada: 66, Germany: 36, and the UK: 42.
But the US regulator’s data is across food, drugs, medical devices, tobacco and so on, says Hussain, explaining why the statistics may not quite give a clear picture of how transgressions by India-based companies stack up against other global players.
Level field
But industry watchers say that instead of quibbling over numbers, it is in India’s interest that companies step up to compete with the big boys on a global stage, and not be found wanting on peripheral issues.
A representative of a multinational company points out that the grievance against Indian drug imports in the US is that they are subject to fewer inspections than US-based companies. And unlike US companies, which are subject to surprise checks, companies in foreign markets know a month or weeks ahead that the regulator is coming for an inspection. The US is making a level-playing field, and if overseas companies want to compete, they should play by the rules, he adds.
Responding to whether local generics players are caught on smaller deviations, judging by the size of the penalties they pay — $500 million by Ranbaxy compared with $3 billion by GlaxoSmithKline or $2 billion by Pfizer — a drug regulatory expert explains that the regulator imposes fines that “pinch” the company, not “sink” it. The idea, he says, is to ensure that non-compliance is dealt with a heavy hand and that errors are not repeated.
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