The implementation of Good Manufacturing Practices (GMP) certificate for both the licensee and the loanee of the ayurvedic medicines under the Schedule T compliance of the Drugs and Cosmetics Act 1945 has come under sharp criticism from the Ayurveda, Sidda and Unani (ASU) manufacturers in the country. They believe that the government decision will only help in creating more problems and regulatory roadblocks to the manufacturers.
Ayurvedic Drug Manufacturers’ Association (ADMA) has demanded the department of Ayush to give the manufacturers a window period of at least two to three years before implementing the compulsory certification of the GMP certificate under the Schedule T compliance of the Drugs and Cosmetics Act 1945.
Department of Ayush through the state licensing authorities is striving hard to implement the provisions of GMP and Schedule T in its true sense. As a part of this initiative the department of Ayush recently issued a notification on the issue of loan license for manufacturing of Ayurveda, Siddha, Unani drugs. They notified that in case of loan license for a particular ASU drug, both the licensee and the loanee must possess the GMP certificate after Schedule T compliance of the Drugs and Cosmetics Act 1945 and related issues.
The idea of implementing compulsory GMP certificate for both the licensee and the loanee is a proactive step. However the way it was implemented in such a short notice have raised lot of criticism from the industry.
Appreciating the intentions of the government, Shashank Sandu, director, Sandu Pharma points out that though the initiative taken by the government is good as it aims at upgrading and improving the infrastructural facilities of the manufacturers, they should also try to understand the genuine concerns of the manufacturers.
He informs that the main reason why a manufacturer in the first place approach a licensee is because they do not have proper manufacturing facilities. In such circumstances implementation of this will adversely affect the manufactures in the country. “It would be imperative for the government to give two to three years of window period to the manufacturers to either set up a proper facility for manufacturing ayurvedic medicines or for upgrading their present facility before implementing it.”
The Department of Ayush stated that they have decided to go ahead with this implementation after a thorough review of the situation of compliance of GMP and shortcomings in its implementation in various states. The notification states that it has been identified that even the license holders of GMP have still to develop a culture of GMP for the manufacturing of the ASU drugs.