PharmaCare Foundation, a Chennai based registered trust to educate the public on safe use of drugs and encourage ethical trade practices, has sought sixty days from the government to comment on the draft guidelines on good distribution practices (GDP) issued by the union health ministry.
In a letter addressed to the drugs controller general of India, R Srinivasan, the managing trustee of the Foundation said the guidelines need in-depth study in order to comment on it and it also needs time to recast the practices relevant to India. He wanted the union health ministry to extend the comment period for two more months for a detailed study of the draft.
Hailing that implementation of good distribution practices is a good gesture towards ensuring the quality aspects of medicines upto the dispensing side, Srinivasan said unless the quality control discipline is imposed by law at all stages like import, manufacture, storage, sale, distribution etc., the patients cannot be assured of the quality and safety of the drugs used by them. The letter to the DCGI says that the initiative to define GDP for pharmaceutical and biological products is appropriate and absolutely essential as the philosophy of ‘drugs control’ is to ensure the quality of drugs.
“Considering the present level of pharmacy and distribution practices prevailing in the country, proper storage and handling of drugs is a matter of serious concern. We have large number of pharmaceutical wholesalers and retailers, but we face shortage of qualified and competent personnel to handle all the stages of the drug delivery system. Besides, the infrastructure facilities required to follow the norms of GDP are also poor. So, the mandatory compliance of the GDP has to be achieved in a phased manner,” the letter to the DCGI said.
He wanted the DCGI that the guidelines should not remain as a text book, but act as a well documented standard operating procedure (SOP) for statutory compliance.
While commenting on the draft guidelines, the pharma expert from Chennai said, “In the context of the prevailing mind-set of the pharmaceutical distributors and retailers, a text book version of GDP will remain as a document of academic interest. Several chapters of it, simply adopted from WHO guidelines, will not be of relevance to Indian context and they have to be recast for adoption as a practice in India. This has to be made mandatory through amendment to Drugs & Cosmetics Act.”
Last month, the union health ministry issued the draft guidelines on good distribution practices for pharmaceutical and biological products to ensure their quality and identity during all aspects of the distribution process.
PharmaCare Foundation provides life saving drugs to the needy patients at affordable costs and encourages ethical promotional and trade practices by manufacturers and trade organisations. It sensitizes the stakeholders to provide pharmaceutical care to patients for achieving definite outcome of drug therapy that improves patients’ life.