Indian generics: Of genuine data issues and ban politics

The see-saw battle between supporters and critics of Indian generics continues, with both groups firmly entrenched in their positions.  For critics, mainly in Europe and the US, Indian generics are all about shoddy quality,  which endanger the lives of millions. For supporters, it is a deliberate propaganda war being waged on behalf of multinationals companies, to prevent low-priced generics from eating into their profits. At stake is a multi-billion dollar drug industry, after all. It comes to a point when editors too side with one or the other skewed view and ensure that the other point of view gets little space.

One the one hand is the inarguable fact that Indian generics brought the prices of hitherto unaffordable drugs, especially the anti-HIV drugs, crashing down. The international medical charity Médecins Sans Frontières (MSF) describes India as the pharmacy of the developing world, and relies of Indian generics for 80% of its HIV drugs supply. Several other international non-profit foundations too depend heavily on Indian generics for their health programs.

Yet Indian generics are under attack, both for quality and India’s patent laws that  include some safeguards in the interest of public health and allow generics production under certain conditions.

Issues of quality are cropping up repeatedly, during inspections by global regulators such as the US FDA or European regulators.

The latest in the saga is the European Commission’s ban on 700 Indian generics, a move that India’s Pharmaceutical Export Council (Pharmexil) estimates  could spell an $12.billion loss to the Indian generics industry. The Economic Times reports that India may contest the ban.

The EC ban,announced on 16 July and expected to be come into effect from 21 August, is based on flaws detected during inspection of clinical trials conducted by a Hyderabad-based firm GVK Biosciences. The flaws pertained mainly to “data manipulations” of electrocardiograms (ECGs) conducted of patients during studies on several generic medicines.

At least FDA has repeatedly clarified in email responses to me that the issues that come to notice during inspections in India are the same that come up elsewhere and there are no reasons to single out India among other countries where it has noted shortcomings, be it in quality or procedures followed.

And at a biotech meeting in New Delhi in March, Bangalore-based Biocon‘s CEO Kiran Mazumdar Shaw said,” Stop India bashing”, saying only the Indian cases get highlighted, while no one reports on US or European firms that are also pulled up.

Some leading Indian biotechnologists, meanwhile, acknowledge that several Indian drugs firms tend to slip up in data integrity, being singularly lax in  data collection and records maintenance. It may not seem a big deal to the person recording the data whether the batch of drugs was inspected at 2.00 pm or 2.10 pm and whether s/he filled in the observations immediately after inspection, or later, say the next day. But it is a major data discrepancy as far as global inspectors are concerned, and rightly so.

It is worthwhile to note, says Krishna Ella, founder of   Hyderabad-based Bharat Biotech, that the issues that come up during inspections are less to do with poor manufacturing quality, and more to do with data quality.

A recent Ernst and Young survey, which drew responses from 170 people associated with the Indian pharma industry, found lax documentation, absence of data reviews, and severe work pressures to demonstrate key performance indicators of products.

It would be in the interest of Indian drug firms to pull up their socks and avoid slip-shod data maintenance. Otherwise, their brand value suffers — and they give the generics critics a stick to beat them with.


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