India Needs To Increase Quality and Stability Of Generics To Be On Par With Global Standards: Haryana DC

India Needs To Increase Quality and Stability Of Generics To Be On Par With Global Standards: Haryana DC

New Delhi, 5 Aug 2019:


Given that India is emerging as a big manufacturer and supplier of generic drugs for domestic as well as global markets, the big question is how we can increase and better the quality and stability of the drugs we manufacture and what strategy we need to adopt for a quality change, comments Narendra Kumar Ahooja, drugs controller of Haryana.


Generics are not new drugs and the quality of Indian generics is widely accepted as good. But we need to change the perception of quality of drugs in India with that of the global, he says.


In an exclusive interview with Pharmabiz at his office at Panchkula in Haryana, Ahooja said the primary requirement for manufacturing better quality stable generics is to adopt most modern technology and procedures. The manufacturing units in the MSME sector should be provided the technological know-how and state-of-the-art facilities.


Commenting on his report to the Drugs Consultative Committee, as member of the sub-committee for Formulation Development Document, Ahooja says that companies who conduct stability studies in most modern laboratories can transfer the procedure of technologies to other companies through Technology Transfer Agreement (TTA) for the purpose of increasing the quality. This can be undertaken only for generic formulation development.


"MSME units can take the procedure of technology from those companies who have already established the particular stability of the formulation by way of TTA. This is only for generic drug production. With this they can avoid the unnecessary duplicity of studies or studies to be undertaken differently by different stakeholders or manufacturers. Technology Transfer Agreement will reduce the burden of the small scale industry," he expressed the hope.


He said his report was approved by the DCC and directed to all state authorities for follow up action.


According to Ahooja, the drugs control department in Haryana is encouraging the generic manufacturers for technology transfer. Companies who conduct stability studies in the modern lab set up at the Common Facility Centre (CFC) are being advised to share their technology procedures to those who want to enter into generic production. Pharmabiz