The Confederation of Indian Pharmaceutical Industry (CIPI), the largest pharmaceutical industry association in the country may strongly object to the Mashelkar Committee recommendations if the committee fails to deliberate the recommendations in detail with its representatives before submitting its final report.
The association feels it would be grave injustice on the part of the panel not to give a detailed hearing with SSIs on proposals like setting up of centralized system for approval of drug manufacturing facilities in the country.
"The committee should discuss with the industry representatives on issues related to industry. They should ask our opinion on crucial issues like implementing a centralized licensing system for drug licenses before proposing and legislating it. They should clearly reveal the modalities of implementing it, how it would be beneficial to Indian industry, practical difficulties involved etc," said T.S.Jaishankar, chairman of CIPI.
"The industry is surely concerned about a new licensing system. We represent more than 19,000 SSI units in different parts of the country, a major chunk of pharma units in India. If the committee decides to ignore our opinion in policies that could severally affect us, then we might be forced to seek other options like legal remedy, if detrimental to our interests," Jaishankar said.
It is to be noted that the Mashelkar panel, which is in the process of submitting its final report by mid-November, had recently met the Madhya Pradesh SSI representatives to get a view of the problems faced by SSIs in the country, apart from its discussions with IDMA, which predominantly represents the bulk drug manufacturing sector in the country. The Delhi Bureau of Chronicle Pharmabiz had already reported that the Madhya Pradesh association, which represented SSIs before the panel, called for a national debate on the committee recommendations before implementation.
Jaishankar said the association was planning to meet R.A.Mashelkar, Chairman of the panel, and represent the SSI industry stand on the issue.
The CIPI Chairman noted there were many practical issues to be addressed before implementing a centralized drug licensing system. Prime concern is the feasibility in setting up a centralized licensing mechanism that could facilitate easier and speedy licensing norms.
"We are not sure whether the existing state drug officials would have powers to issue licenses after inspection in the new system. How far it is possible to enforce a new mechanism, at a stage when most of the state departments lack enough manpower, though having different zones and zonal inspection system to cover the vast geographical areas. Another concern is the procedural delay that could happen in a centralized system", said the CIPI Chief.