With a view to reduce India's dependence on imports of bulk drugs, the government is contemplating to formulate foreign trade policy focused specifically for setting standards and limiting imports of APIs. This move is mainly aimed at checking unrestricted imports from countries like China resulting in serious quality issues and also to encourage domestic manufacturing of bulk drugs with key focus on exports.
It is understood that to fast track this agenda, the government has asked the CII and Sun Pharma to finalise the list of imported APIs taking into consideration the volume and value of the requirement for both the domestic consumption and total consumption including export. It is also focussed on tracking and controlling the share of domestic production which is decreasing drastically due to cheaper imports.
According to Nipun Jain, chief executive officer, of Pharmchem, this is very crucial move directed by the centre, as there is no exact data on how much APIs are imported into India. Having a detailed data pool on the bulk drug import will help the government decide the criteria on import, need of the drug and any other as deemed fit. In spite of India having huge potential for manufacturing bulk drugs domestically, almost 80 per cent of the India's imported bulk drugs are from China, which many feel will kill the domestic manufacturers if government does not intervene.
Government is also said to be probing and identifying those imported bulk drugs which have significantly affected the domestic manufacture to bring in controlled import and push domestic manufacturing. With an aim to create a level paying ground, the Centre has directed CII and Sun Pharma to gauge its impact and suggest changes after deliberation with the stakeholders with justifiable fiscal incentives. It is understood that one of the key focus area is not only to control import but also expand export potential.
In a meeting held in late June, the government decided on doubling the R&D efforts in bulk drug for improvement of process technology by encouraging the same. With a view to promote and encourage research and exports the Centre is also looking into the possibility of setting up mega parks in any of the Petroleum, Chemicals and Petrochemicals Investment Regions (PCPIR) of Gujarat, Seemandhra and Tamil Nadu.