The Office of the Drug Controller General of India (DCGI), according to reports, is considering linking regulatory approval of medicines to their patent status, i.e. DCGI would deny marketing approval to a ‘generic applicant’ if the product is already ‘patented’ in India and the patent has not expired.

This move by the DCGI is seen as inflicting a great degree of servitude upon India’s generic drug industry. The prime reason being thought of is that the Indian domestic pharma industry’s strength, despite the introduction of product patents, continues to be its competence to develop and produce generic medicines. The case for generic drugs is further strengthened by giving examples of U.S. and Canada which follow the system of patent-linkage-to-regulatory approval but with lots of checks and balances to ensure that the generic initiatives are not thwarted. The US-FDA upon receiving an application for a generic drug, issues a notice to the patent holder who then has forty-five days to sue the generic applicant. There is no impact of the patent status on the regulator’s decision either when the generic applicant is sued or not. The regulator can still give the generic applicant the marketing nod, when sued, if the court fails to give its verdict within thirty months.

Taking this development of linking drug marketing approval with patenting as beguiling of the DCGI by the Big Pharma (pioneer drugs makers), the reports argue against it. Their viewpoint is that what is patented and what is not is a substantive and technical issue to be decided by patent authorities, appellate tribunals and courts. The drug regulators, who assess the quality, safety and efficacy of the pharma products and decide on pleas of manufacturing / marketing approvals, need not try and grapple with the complexities of the patenting issue. The right policy is to let the generic applicants take the risk of patent infringement. The Delhi High Court’s recent decision allowing Cipla to manufacture and sell generic version of Roche’s patented anti cancer drug Tarceva (Erlotinib) in India, which catapulted the innocuous marketing approval of generic versions of patented drugs into a highly charged debate, is felt to be in consonance with the principle of taking the risk of patent infringement thus, treating marketing approval and patenting separately. As a result if the patent is finally validated by the court and infringement is established, Cipla will have to sufficiently compensate Roche.

According to reports, the Indian Patent Act balances the interests of patent holders and public health and any digression like the linking of regulatory approval with the patent status would be disparate when even the developed nations now being amenable to adopt generics friendly policies in the wake of a huge demand for cheap generic medicines.