India’s drug price regulators have initiated plans to widen their pharmaceutical drug pricing controls to include the retail pricing of imported drugs. The new plans may provide yet another hurdle to multinational companies attempting to enter or bolster their drug businesses in India.

The National Pharmaceutical Pricing Authority has written to the Department of Pharmaceuticals to amend the nation’s Drugs Prices Control Order, enacted in 1995 and providing foreign drug developers the ability to set prices for drugs they import to India.

The NPPA is hoping their amendment request will offer them the ability to seek details of the methodology adopted by importers to arrive at the fixed price of their drugs.

“There is an impression among some quarters that some companies are launching their drugs in India by declaring a much higher price (than cost of the drug),” National Pharmaceutical Pricing Authority chairman CP Singh told the Economic Times. “We want to have some control over this in public interest. Today, we are completely blind (to) how they have arrived at the landed price.”

Singh made his comments as India moves to finalize a drug pricing policy that aims to move the number of price-capped drugs to 348, from 74.

The case of Bayer’s pricing of the cancer drug, Nexavar, in which Bayer has been required to issue a compulsory license to an Indian generics company allowing it to sell a cheaper version of Nexavar, remains a hot topic. Bayer has appealed the order, but while India’s Intellectual Property Appellate Board has heard arguments, it is still deliberating on a final decision in the matter.

For the Indian government, the newly proposed amendments support its proclamation that prices of lifesaving drugs shouldn’t be determined by market forces, especially considering that Indians pay 70 percent of their healthcare expenses out-of-pocket due to lack of insurance.

However, Tapan Ray, director general of the Organization of Pharmaceutical Producers of, argues that restrictions to patented drug prices will only dissuade foreign pharmaceutical companies from wanting to do business in India. “Any price control in that area will stifle [research and development] initiatives seriously, adversely affecting patients’ interests in the long run,” Ray told The Wall Street Journal.

Striking a cohesive balance, however, is India’s best bet, according to Murali Nair, an Ernst & Young partner, as reported in The Journal. The pricing of patented products should definitely be respected, but in the same breadth their prices should take into account a country’s purchasing power the per capital income of its people. “We need to take a very holistic, public view rather than a very narrow product view,” says Nair.