The Parliamentary committee on subordinate legislation to study the implementation and impacts of revised Schedule M in the pharma industry sought explanations from the drug regulatory authorities on issues related to the implementation of revised Schedule M and the obstacles faced by the industry in complying the norms, according to sources.
The committee, headed by Dr Najma Heptulla, held its second meeting at Chennai on February 8 is also mandated to look into the enactment of Central Excise duty norms. It held discussions with the representatives of SSI pharma organisations and senior officials from the concerned departments.
The objective of the committee includes seeking feasibility of all the norms under the revised Schedule M and to check whether the norms are relevant in Indian context. The committee is expected to finalise the report within a short period and the observations and recommendations will be submitted soon, sources close to the development told Pharmabiz.
Other members of the committee are Prof P J Kurien, Praveen Rashtrapal, Mabel Rebello, Abani Roy and N. Jothi (all MPs), Deepak Goyal, Director and Mahesh Tiwari, Under Secretary of Rajya Sabha Secretariat. They also visited a few small and medium scale-manufacturing companies to analyse the process. The committee's first meeting on the issue was held nearly a year ago.
When contacted, sources from Confederation of Indian Pharmaceutical Industry (CIPI) expressed hope on the committee meeting. Though refused to reveal much on the meeting to maintain confidentiality, the CIPI informed that it has made a representation to the committee with their views and opinions on relevant issues. The CIPI was the only representative of small-scale pharmaceutical sector called for the meeting at Chennai.