A three-member committee has been formed to finalise the guidelines for good distribution practices (GDP) for pharmaceutical products and to suggest methods for the implementation of the same by the state drug control authorities.
The panel consists of director general of drugs, Andhra Pradesh, drug controller of Odisha and ADC (I) North Zone Naresh Kumar as the convener. Rubina Bose, ADC(I), HQ, New Delhi will assist the committee in providing necessary documents for consideration.
The CDSCO had prepared guidelines on GDPfor pharmaceutical products and the draft had been published for comments. Official sources said large number of comments had since been received from various stakeholders like chemists and druggists associations, individuals, manufacturers associations etc. The committee will now finalize the guidelines after consideration of the comments received and suggests methods for implementation of the guidelines by the states.
The guidelines apart from giving general principles and have enumerated detailed guidelines for organization and management, personnel, quality system, warehousing, temperature controls, transportation, documentation etc. including guidelines for recalls and returns.
Recent meeting of the Drugs Consultative Committee (DCC) has also endorsed the move to put in effect the guidelines. “The members opined that guidelines on GDP for Pharmaceutical products is the need of the hour as India is a vast country having major variations in temperature and climate. To ensure quality and identity of pharmaceutical product, the criteria of the drug being tested by the manufacturer before release for sale is not sufficient and it is essential that an adequate control over the entire chain of distribution is maintained so that the quality of the drug does not deteriorate during transportation. The guidelines prepared by the CDSCO should be finalized in consultation with the stakeholders as well as the regulatory authorities,” the DCC said.
It is pointed out that various individuals and entities are responsible for the handling, storage and distribution of the pharmaceuticals products. This includes procurement, purchasing, storage, distribution, transportation, documentation and record keeping practices. To maintain the original quality of the pharmaceutical products, adequate control over the entire chain of distribution is required to be maintained. Each activity in the distribution system is required to be carried out in accordance with the principles of GDP.