New bulk drug policy placed before the Cabinet

A new policy to boost indigenous production of bulk drugs, required to make the formulations, has been put up before the Union Cabinet for its approval.

While India is self-sufficient in formulations, the country imports large quantities of active pharmaceutical ingredients – predominantly from China – for use by the drug manufacturers to make the formulations.

The bulk drug import bill was Rs 17,944 crore in 2013-14 and is steadily on the rise from 2011-12 when it was Rs 14,288 crore.

“Promotion of bulk drugs is high on our agenda. A bulk drug policy is on the anvil as it has been placed before the Cabinet,” said Ananth Kumar, the Union minister for chemicals and fertiliser. The department of pharmaceuticals comes under the Ministry of Chemicals and Fertiliser.

While the minister and officials from the pharmaceutical department refused to speak about the policy’s salient features, the policy document is expected to incorporate the recommendations of an expert panel – headed by former head of the Indian Council of Medical Research V M Katoch – that examined the issues.

The Katoch panel is understood to have suggested a package of interventions and concessions required to build domestic production capabilities. 

A national centre for carrying out research and development on bulk drugs has also been proposed for which the department has earmarked Rs 20 crore in 2015-16.

One of the recommendations of the Katoch panel  to set up an empowered panel of secretaries headed by Secretary, Pharmaceuticals, and comprising of secretaries in environment, commerce and industry ministries has already been implemented.

“The industry can now approach this core committee for any problem they face,” Kumar said.

Other recommendations

Other recommendations include making land available at concessional rates, setting up of mega pharma parks, arrange continuous power supply and removal of cross subsidy charges that account for almost 50 per cent of power charges.

As India meets about 80 per cent of its demand of bulk drugs from Chinese imports, the government intends to set up greenfield pharmaceutical manufacturing units besides improving the brown-field ones.

“Revival of sick public sector units are essential to improve the API production capacity,” the minister said. Hindustan Antibiotics Limited and Indian Drugs and Pharmaceuticals Limited are sick units while Bengal Chemicals and Pharmaceuticals Limited is on the path of revival after Rs 207 crore was infused in the company.