The Federation of Small Scale Pharma Industries of India (FSSPII) has pleaded with the Union Minister for Health and Family Welfare to implement suggestions in Dr Najma Heptullah Parliamentary Committee Report on revised Schedule M norms as early as possible.
The Federation, in an effort to save a number of small scale companies faced closure with the implementation of revised Schedule M norms, has urged the minister to revoke cancellation of licenses of a large number of small scale pharma companies executed during implementation of the revised Good Manufacturing Practices (GMP) norms.
"The Najma Heptullah Committee has suggested that the mandatory installation of air handling units and various other space constrains implemented through the revised schedule should be evicted from the GMP regulation. With the new government taking charge, we are asking the minister to consider the report and save the small scale companies and its employees," said Dr T S Malvankar, president, FSSPII. The government has not yet tabled the report in the parliament though it was submitted by the committee more than six months back.
The Federation, while congratulating the move of the health ministry to revamp the three vaccine units shut down by the last minister, also plead the government to take similar stand on the small scale pharma companies forced to close down due to the stricter norms.
Further, the association also opposed the latest decision of the government to centralise issuance of WHO GMP and Certificate of Pharmaceutical Product (CoPP), alleging that the move would in effect curb the exports growth of small scale companies in the country.
"Now, to obtain product approval from local FDA and GMP and CoPP Certification from Central Drug Authority will be a dual procedure. This is an unnecessary harassment which may cause a great impact on export and government is likely to lose valuable foreign exchange. The small scale companies in distant parts of the country would find it difficult to get product approval from the central authority and will eventually lose the current advantage in exports business," added Dr Malvankar.
In a letter to the Health minister, the federation also suggested that the stringent regulations under the Good Laboratory Practices (GLP) should be loosened to help the small scale pharma industry. With all the regulations and regulatory decisions, the small scale companies in the country is facing serious threat of closure, he averred.