Govt Issues Guidelines on Good Distribution Practices for pharmaceutical products, invites comments

All the stakeholders are requested to forward their comments/ suggestions within a period of three weeks through e-mail to dci@nic.in &dccdtab@cdsco.nic.in for consideration and finalization of the said Guidelines.

New Delhi: Distribution is an essential activity in the integrated supply-chain management of pharmaceutical products. Various individuals and entities are generally responsible for the handling, storage and distribution of such products. So it’s very important to have adequate controls over the entire chain of distribution. To maintain the original quality of pharmaceutical products, every party involved in the distribution chain has to comply with the applicable
requirement

Through a recent notice Ministry of Health & Family Welfare, Director General of Health Services Central Drug Standard Control Organisation (CDSCO) has issued a draft Guidelines on Good Distribution Practices for pharmaceutical products.

The notice states that The Central Drugs Standard Control Organization (CDSCO) in view of the above, all the stakeholders are requested to forward their comments/ suggestions within a period of three weeks through e-mail to dci@nic.in &dccdtab@cdsco.nic.in for consideration and finalization of the said Guidelines.

Through the notice, CDSCO has ordered to maintain the quality of the Pharmaceutical Products, adequate control over the entire chain of distribution is required to be maintained. In this regard, CDSCO has prepared draft Guidelines on Good Distribution Practices of Pharmaceutical Products.

The implementation of Good distribution and storage practices was deliberated in the 54th meeting of Drugs Consultative Committee held on 30.07.2018 and it was suggested to take necessary provisions to impart legal sanctity to the suggested Guidelines as Schedule to the Drugs 86 Cosmetics Rules, 1945 to penalise the offenders.

These guidelines are intended to be applicable to all persons and outlets involved in any aspect of the storage and distribution of pharmaceutical products from the premises of the manufacturer of the product to the person dispensing or providing pharmaceutical products directly to a patient or his or her agent. This includes all parties involved in trade and distribution of pharmaceutical, including the manufacturers of bulk, finished products, wholesalers, as well as others such
as suppliers, distributors, Government institutions, international procurement organization, donor agencies and certifying bodies, logistics providers, traders, transport companies and forwarding agents and their employees as well as health workers.

It also covers biological products in general.

Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable. The nature of the risks involved is likely to be similar to that for risks encountered in the manufacturing environment, e.g. mix-ups, adulteration, contamination, cross-contamination, spurious.

Further, the involvement of unauthorized entities in the distribution and sale of pharmaceutical products is a particular concern. Only a joint approach of all parties involved in the supply chain can be successful in the fight against spurious/sub-standard pharmaceutical products. Therefore, all parties in supply chain shall take an active part in collaborative activities to protect the pharmaceutical supply chain against the penetration of spurious/substandard pharmaceutical products.

Attached is the notification below