The Department of Pharmaceuticals (DoP) is working on the possible ways to help out the small and medium scale units for complying with Schedule M norms as part of the comprehensive proposals to be submitted to the Planning Commission for the next Five Year Plan period.

The third meeting of the Sub-Working Group on Regulatory Issues, under the Working Group set up by the Planning Commission, was held here recently and discussed the issue of helping the remaining SME units to go for Schedule M norms. The meeting, chaired by Devendra Chaudhry, Joint Secretary, DoP, was attended by officials from different ministries and leaders of the industry and discussed in details the regulatory problems faced by the industry in general and the SMEs in particular.

The sub-committees formed by the DoP as per the instructions of the Planning Commission will submit the reports by July 30 and the DoP Secretary will forward the compiled report for the pharma industry to the Planning panel by August 30. All the sub-groups have held several rounds of meetings and the process is in progress, sources said.

The Department, based on the recommendations of the working groups, is expected to submit a number of packages meant for the industry during the 12th Five Year Plan period. One of the key issues, as discussed in the last meeting, was giving assistance to the SMEs in upgrading themselves to the global standards, sources indicated.

The Secretaries in the Departments of Health, Biotechnology, Science and Technology, Commerce and DIPP, Advisors in the Planning Commission, DCGI, member-secretary of the NPPA, Development Commissioner of the MSME, Pharmexcil official, and representatives of all leading pharma associations are the members of the sub-group on regulatory issues.