Following the initiative from the commerce ministry and its set of draft suggestions, the health ministry has launched efforts by consulting the pharmaceutical industry to examine and suggest amendments in the definitions of spurious, adulterated and misbranded drugs under the Drugs and Cosmetic Act.
The move in general is to suggest required amendments so that trademark and patent issues do not get mixed up in the quality aspect of drugs. The definitions under the Act are being reviewed in the context of present knowledge and trade practices, not just within the country, but also at the international level. There has been demand from different quarters to bring in absolute clarity in the laws as often industry faced lots of trouble especially abroad when counterfeit issue was linked always to the trademark laws.
A meeting, convened by the health ministry on March 12 and attended by the officials from the commerce ministry, Department of industrial policy and promotion, ICMR and the pharma organisations, supported the suggestion of the commerce ministry to delink the trademark aspects from the D&C Act and brought totally under the Patent Act. However, it was a preliminary meeting in this regard to garner the views of the stakeholders to see if there is a need for reviewing the definition, sources said. As the issue is considered to be deep and having wider ramifications both nationally and internationally, it will be discussed at wider levels, sources added.
IPA, IDMA and FOPE represented the pharma industry in the meeting. However, the small scale pharma players, who form the majority of the industry and have been instrumental in keeping the drug prices under check, are peeved at the government move to exclude them from the crucial talks being held.
SME Pharma Industries Confederation (SPIC) and CIPI have been left out from the talks. The invitation letter, sent by the DCGI, was only addressed to IPA, IDMA, FOPE, along with Department of Pharmaceuticals, Commerce Ministry and Department of Industrial Policy. "This is a crucial matter and opinion of the thousands of SME units also must be taken into account. Moreover, some of the proposals will have direct bearing on small scale units and they should also be involved," a senior leader representing SME industry said.