Officials in the health ministry said that this could be one method to ensure accessibility to such products, but added that it would be in the company's own interest to ensure affordability of these drugs.

"If the product in question falls within the criteria for inclusion under the DPCO, price control can be resorted to. Besides, the National Pharmaceutical Pricing Authority (NPPA) can also take up such cases with the company concerned to ensure affordability," officials say.

The main criteria for inclusion/exclusion under the Drugs Price Control Order (DPCO) are: 1) drugs under price control should have aminimum annual turnover of Rs 4 crore; 2) drugs of popular use, in which there is a monopoly situation, will be kept under price control. A monopoly exists if for any bulk drug, with an annual turnover of Rs 1 crore or more, there is a single formulator with a market share of 90 per cent or more; 3) drugs in which there is sufficient market competition viz. atleast five bulk drug producers and atleast 10 formulators and none having more than 40 per cent market share in the retail trade (as per ORG) may be kept outside price control.

Industry experts, however, claim that Drug Price Control Order will not be able to ensure cost-effective pricing, given that the legislation considers the material cost and conversion cost and allows a mark-up on this while fixing selling prices.

"If the material cost itself is inflated using unrealistic transfer prices, there is no way that DPCO can ensure rational pricing. In a monopoly situation, the company can dictate prices," they add.

Proponents of product patents,however, claim that the entire issue is based on the premise that product patents will lead to a monopolistic situation. "There will always be effective substitutes for any patented product. So this will, by itself, check prices. Moreover, unless the new drug offers better therapeutic value, it will not be able to compete in the market," they add.