The reported move of the Central Government to define new chemical entities (NCE) by including derivatives like salts, esters, polymorphs, combinations or novel drug delivery systems (NDDS) and bring it within the purview of data protection will ultimately kill the domestic industry, fear industry sources.

They cited that the move would cause to either stall or discard the NDDS programmes undertaken by the Indian pharma companies so far. The industry would not be able to launch any new products in the market in the near future, at least for three to four years, if the government accepts the recommendation. Further, the domestic manufacturers will be forced to spend crores of rupees for developing with a new product, as the drug could be launched only after going through phase I to III trials.

So far, basic research to develop a drug was not in the agenda of India companies and their NDDS programmes hinged on various process changes for formulation development. Sources cited that by the new definition, every NDDS of the existing generics would also be considered as NCE and will have to go through phase I to III trials. Apart from the major Indian companies who earmark crores of rupees of their profit for NDDS programmes, most of the healthy small and medium Indian drug companies spend an average Rs.50 lakhs to Rs.2 crores every year for their NDDS work. All this money and effort would be washed out, along with the advantages and strengths of the Indian pharma industry, say sources.

“Even the US FDA does not consider derivatives as NCEs. To my knowledge, no other country defines NCEs like this,” said Manisha Banavalikar, clinical research manager of Ethypharm Pvt. Ltd., Mumbai, a drug discovery solutions company. She asked for whose interest was the government coming out with a definition like that.

According to T.S. Jaishankar, chairman of Confederation of Indian Pharmaceutical Industries (CIPI-SSI), the government should mandate only BE/BA studies instead of phase I to III trials, if it is keen to define NCEs. He alleged that the move was a part of an MNC ploy to kill domestic industry and cited all of the recent policies of the Central Government favoured only the interests of multinational drug majors and Indian multinational drug companies.

“CIPI would soon submit a representation to the central Government opposing the move,” said Jaishankar.

According to sources, the data protection committee headed by the secretary of Ministry of Chemicals and Petrochemicals is seriously considering to define NCEs by including derivatives like salts, esters, polymorphs, combinations or NDDS, as part of strengthening the data protection norms in the changed product patent era. The committee is likely to come out with its report soon.