India’s long-delayed new pharmaceuticals policy has received another setback, due to concerns by the group of ministers (GoM) set up to examine the policy over the Ministry of Chemicals and Fertilizers’ proposal to establish a separate department for pharmaceuticals.

The Ministry has drawn up the draft new drug policy and is the administrative ministry for the pharmaceutical sector, with responsibilities including drug pricing regulation, but the Health Ministry deals with marketing approvals and quality control.

Health Ministers are said to be unhappy with the policy because they feel it should not cover their drug supply and quality responsibilities, and also point out that certain proposals in the draft policy are already covered by amendments to the drugs and cosmetics act currently going through India’s upper house of parliament, the Rajya Sabha (Council of States), including the setting-up of an autonomous pharmaceutical regulatory agency.

In all, seven government ministries currently have some involvement in regulating the pharmaceutical industry. Officials have warned that a separate pharmaceuticals department within the Ministry of Chemicals and Fertilizers - and headed by the Minister, Ram Vilas Paswan - would cause conflicts, as the sector’s regulator would also be an industry player through its involvement in state-run drugmakers.

However, supporters of a separate department say that it is essential if the massive potential of India’s drug sector is to be fully exploited, in the same way as a separate department of information technology has been set up within the Ministry of Communication and IT.

The Health Ministry expressed its opposition to the plan last week, during the GoM’s fourth meeting on the draft drug policy to be held since the group was set up in January 2007.

- Meantime, Indian ministers are also considering proposals to curb promotional spending by drugmakers and require firms to pass on the savings made to consumers. A meeting of the Pharmaceutical Advisory Forum (PAF) set up by Mr Paswan has heard that, under the current system, the National Pharmaceutical Pricing Authority (NPPA) tracks the prices of medicines once they are on the market but has no power to curb the price set by manufacturers at the product’s launch. Therefore, no price control policy can be effective, said the group.

The PAF has set up an expert group to examine drugmakers’ pricing practices and make recommendations, which could include establishing price controls at market entry level. The Forum has also proposed steps to ensure the availability of generic versions of essential drugs and discourage government hospital doctors from prescribing branded medicines.