On May 22, 2015, the European Medicines Agency (EMA) reaffirmed its recommendation to suspend a number of medicines for which bioequivalence studies were done by GVK Biosciences in Hyderabad, on behalf of several marketing authorization holders in the European Union. This was on the basis of a re-examination requested by the affected parties. And the suspension is for two years.
Bioequivalence (BE) studies are done to prove that a generic product is not significantly different from the reference-innovator product in the extent of availability at the site of action in the body.
“The inspection revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which appeared to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the conduct of trials at the site generally and on the reliability of data generated,” EMA said in its communication to the press.
GVK and its backers are crying foul. The regulators pointed out the ECG studies were not actually done for the medicines concerned but appeared to be manipulated computer printouts. The response of GVK and its supporters carried a suggestion that there was “stricter” enforcement because of being an Indian generic company: a line of argument that has no place here as these requirements and rules were made for all and not “targeted” at Indian pharma companies.
GVK’s status incidentally is of a contractor, and its clients, the marketing authorisation holders, are not all of Indian origin. They were marketing, in EU, generics manufactured in India by India based pharma companies.
Somewhere along it is implied that if a contractor (GVK) infringes quality standards, the principals (marketing authorization holders) have no liability. Try arguing that for builders and their contractors.
It is even argued that these are non-trade “barriers” and these have to be “negotiated.” This is rich. Yes there can be subjectivity in the formulation and application of scientific standards. But it is indeed strange, if not irregular, to hope to “negotiate” BE standards and requirements after the event, to be applied retrospectively, when on the contrary you ought to have known fully the regulatory requirements in advance. Therefore this is not a trade issue but a regulatory issue – and hence appealing to the WTO (World Trade Organisation) Dispute Settlement Body does not make sense.
Nor does the Government’s act of bravado make sense in cancelling ongoing trade negotiations with EU – a move that will hit many other sectors. The Indian government needs to show such proactive zeal in rejecting TRIPS Plus standards in pharmaceuticals – in all Free Trade Agreement talks with EU and others. Nor has it shown courage in issuing Compulsory Licences (CLs) for many overpriced, lifesaving drugs under patents – a legitimate activity under the Indian Patents law as well as under TRIPS. A courage, incidentally, shown by Thailand years ago.
For those arguing for a let off with a slap on GVK’s wrist, here is a question: will you consume a medicine in India if you knew the company was lax in complying with the medicine’s quality standards?
There is however a case for minimizing BE studies involving human subjects in certain product categories. Especially when satisfactory surrogates (substitutes) are available in the form of test tube studies in the lab. Such biowaivers, based on the Biopharmaceutics Classification System (BCS), that take into consideration high/low permeability and/or solubility of the product, have enough scientific backing. They are also mentioned in the EMA guidelines.
Our Government may “negotiate” for these biowaivers after implementing them in India. But for now the likes of GVK Biosciences would appear to be indicted if the findings are true.
(The writer is with LOCOST Vadodara and All-India Drug Action Network. The views expressed are personal. )