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Even after launch of online portal, Bengal traders still forced to visit FDA office for licence renewal

Laxmi Yadav, Mumbai
Wednesday, December 6, 2017, 08:00 Hrs  [IST]

Even though ten months have passed since West Bengal health and family welfare department has launched e-Vesaj, online portal for grant and renewal of drug sale licence, wholesale and retail chemists in the state seeking new or renewal of licences are still forced to submit documents both online and offline thereby leading to duplication of work and causing hardship to licensees.

The online system was notified by the department in January this year making it mandatory for applicants seeking new or renewal of licences to apply using the e-Vesaj system. Unless mentioned otherwise, the existing paper based application will not be entertained by the directorate of drugs control from January 30, 2017, says the notification.

The main objective of the online system was to make directorate of drugs control more accountable, transparent and user-friendly. But the implementation of online system has not yet made drug licensing process hassle-free, and applicants are still making rounds of the drugs control administration for licence and renewal, said Aloke Dey, vice president of Pharmaceutical Traders' Welfare Association of Bengal (PTAB).

The applicants for new or renewal of licences are required to register themselves on e-Vesaj and submit scan copies of requisite documents on the portal. The OTP which is supposed to be sent to the applicants automatically after submitting documents is not automatically generated by e-Vesaj. The users are required to visit the district drugs control office with all requisite documents to get the OTP. The manual generation of OTP by the licensing authority cannot rule out corruption which the state and central governments are willing to abolish, said Dey.

With Union health ministry notifying Drugs and Cosmetics (Tenth Amendment) Rules, 2017 doing away with renewal of licences for the manufacture, sale and distribution of pharmaceutical products every five years, it is blessings for the traders from all relevant hazards of renewal of drug license on completion of every five years.

With the replacement of 'renewal fees' with 'retention fees' through the amendment, the drug licensees started to pay the said 'retention fees' online through a portal of state government and started generating updated status of the valid licenses. These licensees further initiated to send all required papers to the drugs control office for reference and record.

Upset with licensees' move to renew licence through another portal of the state government instead e-Vesaj, drugs control officials have started threatening them with cancellation of renewed licences.

“The drugs control officials are threatening to cancel all such renewed licenses which have been arranged through the official portal of the state government for collecting different license fees and taxes. The licensing authority is denying such process and asking those licensees for resubmitting license fees only through e-Vesaj portal after completing all formalities of registration,” said PTAB vice president.

As per the health department notification, there is no obligation for following the formalities such as e-Vesaj portal. This e-Vesaj portal is mainly an initiative to update the scenario of the pharmaceutical trade and dealers in the state, he opined.

As per Drugs and Cosmetics Act 1940 and Rules 1945, two major documents-- last renewal certificate/renewal receipt and money receipt of the new license fees paid to government are mandatory for any next renewal, yet the West Bengal regulatory authority sought more than 8-10 papers before renewing the licenses of the licensees, he added.

There are reports from various quarters of West Bengal claiming that computer centers in the districts are already involved in a conspiracy and collusion where a huge amount of not less than Rs. 1,000 are charged as processing fees to complete the renewal process through e-Vesaj. One computer center situated outside the Chinsurah drug office is rejecting the appeal of the licensees for complying the entire process through other government portal except e-Vesaj.

We are not against e-Vesaj portal but why OTP generation will be manual and not automated? Secondly it is a portal for updating database of drug licensees. They are required to register on the portal to get licence renewed. The drugs control office having records of drug licensees can upload their database on e-Vesaj portal, but they are shifting responsibility onto licensees, Dey added.

PTAB appealed to the health and family welfare department headed by chief minister to look into the matter and take action to make drug licensing process hassle free.


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