How safe is my drug?

As Indian drug companies get hauled-up by the US regulatory authority and with disconcerting regularity too, consumers across the country may well be apprehensive about the safety and quality of medicines they consume.

After all, some of the biggest names in the business now face the US Food and Drug Administration’s (USFDA) scrutiny for transgressions — ranging from integrity of data to basic concerns over hygiene.

In the last four months, uncomfortable information has come out on deviations at manufacturing units in two high-profile cases involving Gurgaon-headquartered Ranbaxy and Mumbai-based Wockhardt.

As Ranbaxy grapples with the deviations pointed out by the USFDA at its Mohali plant (even as it deals with existing quality concerns at its Paonta Sahib, Himachal Pradesh, and Dewas, Madhya Pradesh, plants), Wockhardt is in the process of setting right quality issues raised at its unit in Waluj (near Aurangabad) and its plant at Chikalthana (Aurangabad).

So if this can happen with large Indian companies and in regulated export markets, is there a cause for concern in the domestic market, where several small- and mid-size companies of different calibre operate? That would be over-stating the concern, says a drug regulatory expert. A company makes a product only after its safety, efficacy and quality have been approved by local authorities. No company gets a manufacturing licence if the authorities are not convinced. So you can consume your medicines without worrying, he says, not getting into discussing unhealthy and corrupt practices that may take place in getting product approvals.

Mistakes will happen. Because an auto major recalls some cars for a technical problem, it does not make the company bad, he rationalises. And it is the same yardstick you need to use when a drug-maker recalls a medicine or is told by a regulator to improve certain processes, he says, adding that if the medicine was indeed harmful, the regulators would have advised consumers to stop taking the drug with immediate effect.

P. Bhaskara Narayana, Director and Chief Financial Officer with Hyderabad-based Natco, agrees, “One need not worry about the quality of medicines coming out from one of world’s largest suppliers of medicines.”

Agreeing that it would be an over-reaction to worry about all medicines, C. M. Gulati, Editor of the drug journal MIMS , points out that attention also needs to be paid to the manner in which medicines are transported and stored, especially since the weather across the country varies from hot to humid to cold.

Making a pertinent observation, a Chennai-based professional adds she would not be worried buying medicines made by known companies if the chemist was reliable and provides her with a regular bill.

Different strokes

The concern is because there are over 10,000 drug-makers and they have old and new manufacturing facilities, some focused on local markets, while others target exports. And to add to the confusion, different regulators have different standards, say industry top-brass.

Pointing out how there could be interpretation issues, Ajaz S. Hussain, former-FDA official and founder of US-based consultancy firm Insight, Advice & Solutions explains that Indian companies generally focus on the end-result of the product, while the USFDA is concerned with the process involved in getting there. Also, under US laws, medicines that do not comply with current Good Manufacturing Practices (cGMP) are defined as “adulterated,” and this is different from the local perception in India where adulterated means fake or spurious.

Another industry representative, with experience across domestic and multinational companies, points out that Indian authorities are focused on issues ofprice control when, in fact, they should be worried about quality. If the Government keeps beating down companies on the price, they may be forced to compromise on quality, he says. In the interest of patient safety, the Government has to be focused on the quality of medicines produced locally. Access can be dealt with, if the Government procures medicines and subsidises then for the people who need it, he adds.

But aren’t there enough laws already to ensure quality? The problem is whether that percolates down the line to be implemented on the ground, he responds. It is open knowledge that the regulatory infrastructure and the number of inspectors available in the country are inadequate, he points out.

Safety first

Admitting that there are good and not-so-good manufacturing sites in the country, an industry official points outthat several large drug companies (domestic and MNC) get a part of their medicines made by third party smaller drug companies. So it is not entirely gloom and doom on the quality front, says a senior legal expert.

There is no doubt that companies need to take quality compliance seriously, understanding the sensitivities when it comes to making a medicine. But for every Jaslok Hospital that stopped using a Ranbaxy drug, for instance, when quality concerns hit the roof, there are also reputed doctors like Devi Shetty, who stood by the medicines made in India, the industry representative points out.

> jyothi.datta@thehindu.co.in

> naga.gunturi@thehindu.co.in

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