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Pharmacy Choice - Pharmaceutical News - Central govts joint inspection idea worries pharma firms [Syrian Arab News Agency] - November 22, 2017

Pharmacy News Article

 4/21/17 - Central govts joint inspection idea worries pharma firms [Syrian Arab News Agency]

Pharmaceutical firms in the state are planning to request the union government to review the proposal of joint inspections of drug manufacturing facilities by central and state licensing authorities. The companies want a single authority to conduct the inspections.

The Draft Gazette Notification GSR 319 (E) released on March 31 by the the union ministry of health and family welfare has proposed that drug manufacturing premises be jointly inspected by inspectors appointed by the central and state governments. The inspectors will verify compliance with the conditions of licence and the provisions of the Drugs and Cosmetics Act, 1940.

Sources in the pharmaceutical industry said currently the state food and drug control authority carries out inspection of pharma plants before granting manufacturing license for any drug. In the case of large volume parenterals or LVPs, vaccines and medical devices, inspection and product approvals are granted by the Central Drugs Standard Control Organisation (CDSCO). (The LVPs are also sometimes called large volume injections.) Viranchi Shah, chairman, Gujarat State Board, Indian Drug Manufacturers` Association (IDMA), said the joint inspection of manufacturing facilities may cause delays in the licensing procedure and make compliance a lengthy affair for pharma firms, especially small and medium enterprises (SMEs).

"We are thinking of requesting the government to review the clause and keep only single authority, either from the Centre or the state, for inspections," Shah said.

He further said that the draft guidance proposes to remove the requirement of renewal of licenses to manufacture all types of drugs for sale or distribution.

"This is a welcome move and is aimed at ease of doing business. Our concern, however, is only about joint inspections. If this is done, it will defeat the whole purpose of ease of doing business," Shah said.

Industry experts maintain that the move might have greater impact on smaller players. Around 80% pharmaceutical units (nearly 700) in Gujarat are SMEs. "We are going to represent to the government over this matter. The issue will be discussed during IDMA`s National Meeting this Friday," Shah said.

(c) International 2006-2017, SANA Provided by SyndiGate Media Inc. (

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