Union Health Ministry To Notify GDP Norms Under D n C Rules To Ensure Quality Of Drugs

Mumbai, 22 Aug 2019:

Union health ministry will soon notify Good Distribution Practice (GDP) guidelines under the Drugs and Cosmetics (D&C) Rules 1945 to ensure that patients get quality drugs.

Comments and suggestions on the same have been received and are in the process of getting compiled based on the Central Drugs Standard Control Organisation (CDSCO) notice to all the state licensing authorities and stakeholders.

Drug Technical Advisory Board (DTAB) in its recent meet deliberated the matter and recommended to amend the D&C Rules, 1945 to include provisions for GDP of pharmaceutical products.

The issue of incorporation of GDP guidelines as a separate Schedule was also deliberated in 56th Drug Consultative Committee (DCC) meeting held on June 1, 2019.

“The objective of the quality control over drugs is to ensure that the patients get quality drugs. For this purpose, it is necessary to ensure the quality and identity of pharmaceutical products during all aspects of the distribution process which includes procurement, purchasing, storage, distribution, transportation and associated documentation or record keeping practices. Each activity in the distribution system is required to be carried out in accordance to the GDP principles,” as per the DTAB recommendations.

The recommendations further stated that the involvement of unauthorised entities in the distribution and sale of pharmaceutical products is a matter of concern as it leads to introduction of spurious drugs in the supply chain. It is the responsibility of all parties involved in the distribution of pharmaceutical products to ensure that the quality of pharmaceutical products and the integrity of the distribution chain are maintained throughout the distribution process.

The said matter was also deliberated earlier in the 47th DCC held on July 30 and July 31 2014 wherein report of the sub-committee constituted for preparation of guidelines on GDP of pharmaceutical products was considered.

The matter was also deliberated further on the 54th meeting of DCC held on 30th July 2018. The DCC then suggested to take necessary provisions to impart legal sanctity to the suggested guidelines as a Schedule to the Drugs and Cosmetics Rules, 1945 to penalise the offenders. Pharmabiz