In a scathing letter to the Government of India, the Indian Pharmaceutical Alliance (IPA) took issue with what it considered to be a backdoor extension for data exclusivity norms in the country. It pointed to the recent government proposal to change the four-year time limit for State-level drug regulatory approvals to 10 years, arguing that this effectively results in a long and damaging data exclusivity.
Data exclusivity is a kind of intellectual property protection wherein clinical trial and other data submitted by an originator drug company cannot be used or relied upon by a drug regulatory authority to approve a generic version of that drug for a certain period of time. The notion is that without such protection, the originator company lacks the necessary commercial incentive to conduct expensive trials and take a potential drug to the market. Blocking generic entry for some years will, the theory goes, help drug companies invest in clinical trials.
Skewing the pharma market?
India has long resisted U.S. and EU pressure to institute data exclusivity norms, seeing it as a barrier to generic entry and more affordable drug prices. However, a rather curious provision in the Drugs and Cosmetics Act (DCA) could arguably constitute a de facto kind of data exclusivity.
Under the Act as it stands now, a new drug continues to remain “new” even after it has been approved once by the Central regulator (Drugs Controller General of India, or DGCI) upon submission of local clinical trial data establishing safety and efficacy in India. However, it loses “newness” after four years, which means a drug manufacturer can short-circuit the process and go directly to a State regulatory authority and procure drug approval. It is this four-year period that is now sought to be enhanced to 10 years, an extension that the IPA argues constitutes an enhancement of data exclusivity norms in favour of large pharma companies, particularly MNCs. Others insist that there is no such data exclusivity norm in India.
Who is right? And who is wrong? This depends in large part on the kind of data that generic companies have to submit in order to gain approval for their follow-on drugs. If they are forced to submit the same kind of clinical trial data that originators have submitted to the regulatory authority, then this does amount to data exclusivity. For almost all generics will simply wait for the term (four years) to expire rather than undertake the expensive process of generating clinical trial data afresh, not to mention the sheer immorality of repeating animal studies and subjecting human volunteers to safety and efficacy tests in relation to the same drug molecule.
It is for this reason that world over, generic drugs are approved upon a simple showing of bio-equivalence: that the claimed molecule is the same as the one already approved. And therefore, there is no sense in having the generic applicant repeat all clinical trials afresh. However, bio-equivalence cannot be had for the asking but must be demonstrated through rigorous studies/data.
Unfortunately, our Act is not very clear on the kind of studies/data that a generic applicant is meant to submit, not least because it is one of the worst drafted pieces of legislation, leaving the bulk of substantive norms in the “rules” and various forms and schedules running to a good 500 pages!
Little wonder then that a number of state regulators do not insist on bio-equivalence studies or any other studies for that matter prior to approving a drug for manufacture in that State. Therefore, any substance held out as a drug (even a complex cancer drug) is likely to make the cut… be it a piece of chalk, cheese or china!
And this precisely is why in our rather complicated federal structure of drug regulation, comprising both a Central authority, namely the DCGI, and a vast array of State-level regulators, drug manufacturers opt to simply wait for four years and then approach State authorities rather than risking a more rigorous Central clearance.
However, this does not mean that all is well on the Central regulatory front. A damning parliamentary committee report some years ago found that in the vast majority of cases, the DCGI doesn’t even insist on separate local clinical trial data for new drugs. Rather they routinely dispense with the requirement of local clinical trials under a broad “public interest” exception.
Lax regulatory standards
In the end, one needs to ask: why have this four-year or 10-year time lag at all for generic drug approval? Shouldn’t generic drugs be approved on Day One, so long as they are able to demonstrate (through bio-equivalence studies and the like) that they are as robust as the new drug that has already been approved once? Why maintain this legal fiction that a drug will remain “new” even after it has been validly approved once (for up to four years or 10 years as the case may be)?
Unfortunately, our drug regulatory regime is callous at best, and murderous at worst, plagued with glaring gaps that are routinely exploited by drug majors — a fact amply demonstrated by a well-researched public interest petition (PIL) by whistle-blower Dinesh Thakur. Unfortunately, the apex court declined to admit his PIL and we lost out on an opportunity to compel a healthier drug regulatory regime.
Pollution is easy to understand. Drug regulatory standards not so. Which may perhaps explain why courts routinely entertain PILs on the former, but shy away from the latter. Even when lax regulation on the latter count is far more dangerous than pollution. For, with each passing day, we’re suffering a regime that kills, albeit all too softly, through a laxity in the law. A laxity that the layman may not immediately grasp. But one which a responsible government (and even judges) should make it their business to study and understand, before it is too late.
Shamnad Basheer is Honorary Research Professor of Intellectual Property Law at Nirma University and founder of SpicyIP.