Backdoor extension of Data exclusivity
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.
What is Test Data exclusivity?
Test 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.
Need to reduce Data exclusivity norms
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.
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.
Whether it really constitutes Data exclusivity
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. 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.