With the small and medium scale pharmaceutical units feeling tremendous pressure in upgrading the lab facilities to comply with the Good Laboratory Practice (GLP) norms, a high-level panel representing industry wants the postponement of the present deadline of November 1, 2010 at least by two years to November 1, 2012.
The voice of the industry came through the subcommittee of the high-level Joint Working Group for building capacity of SME and auxiliary industry. However, the final recommendation of the JWG has not been included in its report submitted to the government, it is learnt.
The subcommittee comprising Lalit Kumar Jain of SMPIC Consultative Committee( NIPER), G Wakankar of IDMA, Dr Sanjay Jachak of NIPER, and Kawaljeet Singh of FICCI, in its report, said the capital cost of upgrading labs would be around Rs. 4-5 crore and operational costs would be around Rs. 65 lakh to Rs. 1.25 crore.
“Improvement of systems and methodology can be implemented within one year, but more time is required for the investment in sophisticated instruments like HPLC and others. The date of implementation of GLP may be amended to November 1, 2012,” the committee suggested.
Meanwhile, the huge investments required for upgrading also has placed the SMEs in an unenviable predicament. “In case, if the SMEs upgrade its laboratory conforming to GLP standards at an estimated cost of Rs. 4-5 crore, the SME units will no longer be small scale or medium scale and would go out of purview of SME category for the reason that this would be treated as investment in plant and machinery. Current limit of investment for small scale unit is Rs. 5 crore and medium scale enterprise is Rs. 10 crore,” the officials of MSME disclosed to the JWG.
“As there is a lot of gap between current practice of SSIs and the newer GLP norms, adequate time should be given to the SSIs for upgrading their systems and train their quality personnel. The Department of Pharmaceuticals through the Planning Commission should provide 50 per cent of grant under the 12th Five Year Plan to SME pharma units who opt for self-upgradation to GLP/WHO GLP instead of joining clusters. Additional investment of Rs. 50 lakh, if provided to SME, they can coordinate working by setting up own R&D centre for process reengineering with a view to reduce cost in comparison to Chinese,” the subcommittee suggested.
The panel also called for changing the present minimum turnover criteria of Rs. 30-35 crore for SMEs to participate in the government tenders. It should be amended to enable the Schedule M-compliant SMEs to take part in the tenders, the sub-committee said.
The JWG was set up under the chairmanship of joint secretary in DoP, Arun Jha, following the India Pharma Summit in November 2009, to formulate the strategy and implement it to enhance the technological physical capacity of SMEs.