The Indian Drug Manufacturers' Association-Gujarat State Board (IDMA-GSB) organised an interactive session between central and state regulators on January 11, 2015 at Hotel Regenta, Ahmedabad.
The session was attended by Sudhanshu Pandey – Jt. secretary, dept. of commerce, govt. of India, Dr. G.N. Singh – DCG (I), Dr. H.G. Koshia – commissioner, FDCA, Gujarat, Dr. S. Ewara Reddy – Jt. DCG (I), Dr. P.V. Appaji, director general, Pharmexcil.
Bharat Desai, Chairman, IDMA-GSB in his welcome address drew the attention of regulators towards various issues pertaining to Drug Act and regulatory matter such as PET bottle, Clinical trial, Printing of prices on scheduled drug, etc.
Dr. P.V. Appaji appreciated the role played by Commerce Ministry and CDSCO to encourage export of pharmaceuticals and noted the Gujarat manufacturers' contribution due to which the pharmaceutical export had reached a new height.
Dr. G.N. Singh said that due to new government all the departments are active and currently they were also working to amend Drugs & Cosmetics Act as well as Rules. He then appealed to submit suggestions for quality manufacturing. adding that they would not compromise in quality production and would see that manufacturers get regular guidance from the regulators.
Sudhanshu Pandey, says, “we do not insist your suggestions in this interactive session but through association select at least three main issues which require immediate attention and send it to regulators. We will see that suggestions are implemented as per act permit. We know it is very difficult to select particular three issues but if we follow such practice we can solve many issues.”
Further, he appreciated Gujarat-based manufacturers for their contribution in export and assured that regulators would receive support when required.
Dr. S. Ewsara Reddy informed the working pattern of Ahmedabad zonal office adding that at present the applications gets cleared within 24 hours. Appreciating the manufacturers of medical devices, he said that Gujarat was progressing in that field.
During inspection regulators will guide manufacturers to comply small issues. Ahmedabad zonal office has implemented 24/7 basis clearances of consignment of imports / exports from January 01, 2015.