The Gujarat drugs control administration's latest move seeking a mandatory affidavit from the pharmaceutical industry for every additional product licenses on pharmacopoeial products has invited sharp criticism from the industry in the state.
The Gujarat Food and Drugs Control Administration (FDCA) has recently issued a circular stating that the pharmaceutical companies should submit an affidavit on a stamp paper of Rs 20 along with any new application for additional product licenses on drugs based on Indian Pharmacopoeia. The new decision is to bring in accountability in licensing procedure and to hasten the disposal of files at the earliest, according to a higher official with FDCA.
As per the circular, the applications which have the affidavit affixed with should be disposed by the respective licensing officer within a period of three days. The state drug control administration, using the provisions in the Drugs and Cosmetics Act, can impose such an administrative decision as its intention is purely to enhance the licensing the procedure, added the source.
"Our intention is to hasten the issuance of product licenses and mandating the affidavit will compel our officers to issue the licenses within three days from the time of receiving the application. This will bring in more accountability and responsibility to our officers as any delay in issuance of additional product licenses make the respective officer answerable to the industry and the higher officials," said H G Koshia, joint commissioner, FDCA, Gujarat.
However, the industry sources said that the administration has imposed the new norm without informing the industry and the sudden mandate has created difficulties to the pharma players in the state. "The FDCA has stopped issuing additional product licenses without the affidavit, which created difficulty to keep up with the plans of the companies especially for the small and medium scale players in product launching. We have contacted the other state associations to know whether there is such a reform imposed in any of the states like Tamil Nadu and Andhra Pradesh. We think that Gujarat is the first state to impose such a norm and we will contact the FDCA for further discussions to ease the mandate," said Dr R S Joshi, executive secretary, Gujarat State Board of Indian Drug Manufacturers Association (IDMA).
"The decision was to help the pharma industry in the state as it fixes some deadline for the officers to issue pharmacopoeial product licenses. However, we will discuss the matter with the industry associations and we are ready to rethink if their points are valid," informed Koshia. Currently, the FDCA is taking more time in disposing each product license application and the new norm was thus to help the industry to avail the licenses in a short period of three days. The FDCA is currently equipped with facilities to issue exports licenses for the products within 24 hours and the target is to hasten issuance of every licenses and certificates in a short timeframe, he added.