Union government has released a Draft Gazette Notification GSR 319 (E) dated March 31, proposing to remove requirement of renewal of all types of licenses to manufacture for sale or distribution of drugs & cosmetics. The regulatory authority expects the industry to share their objections and suggestions before May 15.
According to the guidance, a licence issued in Form 20, 20A, 20B, 20BB, 20F, 20G, 21, 21A, 21B, 21BB, 25, 25B, 25F, 28, 28B, 28D, 25A, 28A, 28DA, 32, 32A, 33 will remain valid perpetually. This is even in the case if a licencee deposits a licence retention fee before the expiry of a period of every succeeding five years from the date of its issue, unless it is suspended or cancelled by the licensing authority.
The licence retention fee will be equivalent to the respective fee required for the grant of such licence. If retention fee is not paid by due date, licensee can pay late fees within 6 months, failing which license will be deemed as cancelled.
The draft guidance has also given considerable importance to the inspection of the premises to verify the compliance with the conditions of licence will happen at least once a year by licensing authority for Form 20, 20A, 20B, 20BB, 20F, 20G, 21, 21A, 21B, 21BB.
Before the grant of licence under Form 25, Form 25A, Form 25B, Form 25F, Form 28, Form 28A, Form 28B, Form 28D and Form 28DA, the premises will be inspected jointly by Inspectors appointed by the Central Government and the State Government. The premises will continue to be inspected once a year by central and state licensing authority to verify the compliance with the condition of license, said the draft guidance note.
In order to make certain total compliance by the manufacturing units, the draft guidance has stated that the Central Licence Approving Authority or the licensing authority, as the case will embark on inspection of each establishment which is licensed. This inspection will be jointly conducted by the inspectors appointed by the Central Government and the State Government under the Act, to verify the compliance with the conditions of licence and the provisions of the Act and these rules at least once in a year.
According to Sunil Attavar, president, Karnataka Drugs and Pharmaceutical Manufacturers Association, as India moves to becoming a Stringent Regulatory Authority country the process of joint inspections for new facilities is a welcome move to enhance the image of the industry in the coming days .
“We believe that the planned annual joint inspection frequency could be risk based and not mandated for every year as it will put a lot of strain on the system to audit each and every license of the drug and cosmetic facility We hope that the process will not be a negative for the MSME sector who form the fabric of the industry and adequate support will be given to bring them up to expectations”, he added.
“ The life time validity of licenses will help in the ease of doing business . There are a few concerns that we trust will be addressed in the final notification like having adequate number of inspectors to facilitate inspections across the country. Also health being a concurrent subject as per the constitution , this process should not infringe or undermine the state licensing authorities , which could be counterproductive,” stated the KDPMA president.