The corporate compliance requirements have drastically changed after the introduction of Indian Companies Act, 2013. Similarly, regulatory framework pertaining to companies operating in India has also been changed. For instance, foreign companies and e-commerce portals would be required to register in India and comply with Indian laws as per changed regulations applicable in India.
Drugs and pharmaceutical industry of India is also witnessing the impact of changed regulatory environment both in Indian market and foreign markets. The generic pharmaceutical companies of India are also passing through tough phase. However, the generic drugs industry of India is also giving sleepless nights to foreign pharmaceutical companies who are finding it difficult to compete with the economies of generics drugs.
As a truce, international drug manufacturers are entering into negotiations and settlements with the generic drug manufactures across the world, including India. However, not all settlements are genuine and in many cases these settlements are unreasonable means to stifle domestic competition that results in higher prices for the drugs in the concerned country. This is clearly an unfair practice and anti competition and anti trade in nature.
It has been reported that the Competition Commission of India (CCI) may examine patent settlements that are being negotiated between foreign brand-name drug makers and domestic generic companies. In these arrangements, a brand-name drug maker reaches a settlement with a generic rival in exchange for ending patent litigation and launching a copycat medicine at a future date. Many have raised the concerns that such deals would restrict access to affordable medicines in India.
CCI is scrutinising the deals between Tarceva lung cancer drug made by Roche and a deal with Cipla and the settlement between Glenmark Pharmaceuticals and Merck concerning the Januvia diabetes pill. In Federal Trade Commission v. Actavis, inc., Et Al. No. 12–416. 570 U. S. (2013) (PDF) the U.S. Supreme Court adjudicated upon a similar complaint of the U.S. Federal Trade Commission (FTC).
CCI also plans to probe the market impact of injunctions that were obtained over the past year by Novartis and Merck against a dozen domestic drug makers, which were prevented from selling copies of diabetes drugs.