Drugs are an integral part of the healthcare delivery system and indispensable for catering to the unmet medical needs of patients. At the same time, it is of paramount importance that such drugs that are administered to patients are safe and efficacious.

To ensure this, every drug that is introduced in the market requires to be tested for both safety and efficacy through an intricate process of clinical trials and post-marketing surveillance. The question is: how much time is reasonably adequate to ascertain that a particular drug is safe for the population to which it is administered.

The Government’s recent plan to increase the “new drug” period from four to 10 years is a step in the right direction from the angle of ensuring patient safety.

However, the move seems to have drawn unnecessary scepticism by the use of such confusing terms as “data exclusivity”. And while data exclusivity is a TRIPS commitment, extending the term of the “new drug” under Rule 122 E of the Drugs and Cosmetics Rules is certainly not data exclusivity.

What’s data exclusivity?

In simple terms, data exclusivity means that a regulatory authority does not rely on either data or results of clinical trials in other jurisdictions generated by original applicants while granting marketing authorisation to subsequent applicants.

It is hard to relate this concept with the move now proposed as under the existing Indian laws, a subsequent applicant is neither prohibited from bringing in its product during the four years (when a drug is new) nor would it be prohibited if the four-year term is extended to 10.

Further, the Central Drugs Standard Control Organisation (CDSCO) continues to rely on clinical and pre-clinical data generated by the innovator irrespective of the length of the New Drug period. Hence, the idea of data exclusivity does not fit into the situation at all.

Uniform process

Extending the ‘new drug’ period to ten years will actually enable establishment of a uniform centralised evaluation process of all new drugs by CDSCO that, in turn, would ensure a robust Chemistry, Manufacturing, and Controls (CMC) documentation and supporting bio-equivalence data fundamental to the manufacture of all drug products.

On November 15, 2016, the Drug Technical Advisory Body (DTAB) recommended that State Licensing Authorities (SLAs) conduct bio-equivalence and stability studies to ensure quality, safety and efficacy.

The truth is that not all SLAs have the capability to evaluate and have continued and robust oversight.

An apt example of such concerns is in the case of FDCs where controversies arose because of lack of regulatory oversight.

New combinations were available in the market which were licensed by the SLAs without proper evaluation of their safety and efficacy profiles exposing patients to adverse drug reactions.

Extending the period of oversight to ten years by the CDSCO is thus a positive development that may help minimise quality, safety and efficacy concerns with drugs.

Finally, it is a no-brainer that patient safety concerns must surmount all other aspects in designing a regulatory regime. It is, thus, unwarranted that a positive policy initiative of the government to enhance its oversight over safety profile of drugs be muddled in debates involving entirely extraneous elements like the concept of data exclusivity.

The writer is Managing Partner, Corporate Law Group. Views expressed are personal.