Following the stiff opposition from the pharmaceutical industry from the state, the Gujarat State Food and Drug Control Administration (FDCA) has decided in principle to withdraw its recent decision to seek mandatory affidavit from the companies for additional product licensing and certificates, it is learnt.

The decision to withdraw the circular seeking affidavits was taken in the middle of August, following a meeting with the Gujarat State Board of Indian Drug Manufacturers Association (IDMA). A circular revoking the usual licensing procedure will be officially sent to the deputy drug controllers under FDCA within a week, according to H G Koshia, joint commissioner, FDCA.

"We have implemented the new system to help the companies in the state to save time in achieving licenses. However, our discussions with the state IDMA members showed that the industry fears more procedural delay through the system. So we have decided to withdraw the affidavit form," said Koshia.

The FDCA, in July, has issued a circular to the deputy drug controllers to seek a mandatory affidavit from the applicants on a stamp paper of Rs 20 for any new application for additional product licenses on drugs based on Indian Pharmacopoeia.

The applicant should state that the brand name is not registered in any part of the country, the product is not coming under the official list of banned drugs, the product is not a new drug and is not a Fixed Dose Combination (FDC) listed by the Drug Controller General of India (DCGI) in the recent list of irrational combinations. Further, the applicant should also confirm that the manufacturing facility where the said drug is manufactured is licensed as per the current norms.

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 decision was to help the pharma industry in the state as it fixes some deadline for the officers to issue pharmacopoeial product licenses," added Koshia. However, the IDMA sources earlier maintained that the system has created difficulty to keep up with the plans of the companies especially for the small and medium scale players in product launching.

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 license and certificates in a short time frame, said the FDCA official.