The Drug Control General of India’s recent decision to delegate more powers to the zonal offices of CDSCO will strengthen the national regulatory body and make help pharmaceutical industry across the country, especially the exporters and importers, according to PBN Prasad, Deputy DCGI, south zone, Chennai.

He was delivering a lecture on ‘CDSCO’S Role in the Current scenario’ in the monthly seminar program organised by IPA Tamil Nadu.

Recently the DCGI has delegated certain functions and powers to the zonal offices under Rule 22 of the Drugs & Cosmetics Act (D&C Act). The delegation of powers empowered with zonal offices came into force on June 20.

According to Prasad, the transfer of powers include issue of NOC for Dual use, NOC for approved/unapproved and banned drugs, NOC for Test Licence in Form 29, issue of licence in Form 12 B and Renewal of certificates for the operation of blood banks which process whole human blood IP and its components.

He said from now on the manufacturers or exporters need not hang in the corridors of the offices of DCGI in Delhi and many of their requirements can be done at the zonal offices. On receipt of any application, the zonal office will acknowledge it immediately and scrutiny of the documents and applications be done as per the guidelines issued by the DCGI. The status report of every application and the actions taken on each application will be displayed on the LCD screen erected on the wall of the zonal office.

According to the guidelines of the DCGI, applications for NOCs for examinations can be submitted to the zonal offices. Applications are required for issue of NOC for the manufacture of unapproved/approved new drugs in Form 29 for the purpose of examination, test and analysis (excluding clinical trial purpose) for drugs other than biologicals/medical devices / diagnostic kits. This guideline will corroborate various commonly found aspect of granting licence in Form 29 for the manufacture of specific quantities of drugs under provisions made in Part VIII of the D&C Act and Rules 1945, he said.

The application should be submitted to the respective zonal office of the CDSCO where the actual manufacturing site is located. The applicant should submit the documents separately for manufacture of API, manufacture of finished products and manufacture of investigational new drugs for their examination, test and analysis.

The deputy DCGI apprised the manufacturers and exporters how to process and submit applications for getting NOCs, Registration and how to undertake due diligence before making applications for import of materials. Further he elaborated on how various kinds of documents can be prepared in order to support the application.

While welcoming the decentralization of powers by the DCGI, J Jayaseelan, secretary of Tamil Nadu IPA said the attempt of the DCGI is praiseworthy and it will bring more benefit to the industry. He said his committee has decided to hold monthly seminars on various subjects inviting resources persons from industry and academia in order to solve the regulatory issues affecting the industry and thereby to benefit the exporters.

Deputy drugs control general of the DCGI office, K Manivannan, IPA TN president K Narayanaswami, P Sabhapathy and former state drugs controller P Selvaraj attended the seminar.