August 12,2024
The Drugs Controller General of India (DCGI), the country’s top drug regulator, has framed standard operating procedure and guidelines to ensure product traceability throughout the supply chain, as the menace of fake and spurious medicines grows.
The DCGI has circulated this good-distribution practice as traceability is a big challenge due to a lack of proper documentation throughout the distribution channel.
The development assumes significance as the Indian pharmaceutical industry has come under global glare following allegations that spurious cough syrups from the country were linked to children’s deaths in Gambia, Cameroon, and Uzbekistan.
In the recent DCGI’s drugs consultative committee meeting held in June, it was decided to incorporate good distribution practice as a Schedule in the Drugs and Cosmetic Rule, 1945.
It was discussed that due to the non-mandatory nature of guidelines, the maintenance of storage conditions of drugs during the transit till wholesale and retail level was not ensured by the manufacturers.
These draft guidelines on good distribution practice have been framed at par with World Health Organization standards and stakeholders can send in their comments and suggestions over the next 30 days, before the rules are finalized.
Drugs & Cosmetics Act 1940 and Drugs & Cosmetic Rules 1945 specify the conditions to be fulfilled to sell, stock, exhibit or offer for sale or distribute the drugs across the country.
The draft guidelines said that individuals such as manufacturers and wholesalers, brokers, suppliers, distributors, logistics providers, traders, transport companies and forwarding agents and their employees are generally responsible for the handling, storage and distribution of pharma products. Therefore, to maintain the original quality of pharmaceutical products, every party involved, such as in the distribution chain, must comply with the standards of good distribution practice.
“Substandard and spurious products are a significant threat to public health and safety. This guideline is meant for those involved in the supply chain of medical items and their active role to protect the pharmaceutical supply chain against the penetration of spurious/substandard pharmaceutical products,” said a state drug controller, requesting not to be named.
“The nature of the risks involved is similar to that encountered in the manufacturing environment, for instance, mix-ups, adulteration, contamination, cross-contamination, spurious. The involvement of unauthorized people in the distribution and sale of pharmaceutical products is a particular concern,” the official cited above said, adding that these guidelines can be used as a tool to curb the distribution of substandard and spurious products.
The guidelines underlined the procedures to ensure a safe, transparent and secure distribution system which includes product traceability throughout the supply chain.
It said that there shall be procedures in place to ensure document traceability of products received and distributed, to facilitate product recall, the guidelines said.
All individuals involved in supply-chain of drugs must ensure that all pharmaceutical products have documentation that can be used to trace the products throughout distribution channels from the manufacturer to importer to the entity responsible for selling or supplying the product to the patient or his or her agent.
Records including expiry dates and batch numbers shall be part of a secure distribution documentation enabling traceability.
It shall be ensured that records of dispatch contain enough information to enable traceability of the pharmaceutical product.
‘Such records shall facilitate the recall of a batch of a product, if necessary, as well as the investigation of spurious or potentially spurious pharmaceutical products; the assigned batch number and expiry date of pharmaceutical products shall be recorded at the point of receipt to facilitate traceability,” it said.
The guidelines also state that senior management of each entity should be responsible for ensuring that an effective quality system is established, resourced, implemented and maintained, and periodic meetings held to review the work.
Source: Drugs Control