DCGI introduces new traceability rules to address fake medicines issue

The new guidelines have been formulated by India's drug regulatory body to ensure product traceability, which has been hindered by insufficient documentation throughout the distribution network

India’s leading drug regulator, the Drugs Controller General of India (DCGI), has established standard operating procedures and guidelines aimed at enhancing product traceability across the supply chain. This move comes in response to the increasing threat posed by counterfeit and substandard medicines, reported Livemint.

These new good-distribution practices have been formulated by the DCGI to address the critical challenge of ensuring product traceability, which has been hindered by insufficient documentation throughout the distribution network, the report said. The ability to trace products seamlessly could prove vital in identifying the exact point in the supply chain where adulteration occurred or where counterfeit drugs were introduced.

This initiative gains importance as the Indian pharmaceutical sector has come under international scrutiny following accusations linking fake cough syrups produced in India to the deaths of children in Gambia, Cameroon, and Uzbekistan.

During the DCGI’s drugs consultative committee meeting in June, it was resolved to integrate good distribution practices into the Drugs and Cosmetic Rules, 1945, as a formal Schedule. The discussion highlighted that due to the non-mandatory nature of existing guidelines, there has been a lack of assurance regarding the maintenance of proper drug storage conditions during transit to wholesale and retail levels by manufacturers.

The draft guidelines on good distribution practices have been aligned with World Health Organization standards, and stakeholders have been given 30 days to provide their feedback and suggestions before these rules are finalised.

The Drugs & Cosmetics Act of 1940, along with the Drugs & Cosmetic Rules of 1945, sets out the conditions necessary for selling, stocking, exhibiting, or offering for sale or distribution of drugs throughout India.

According to the draft guidelines, individuals involved in the handling, storage, and distribution of pharmaceutical products — such as manufacturers, wholesalers, brokers, suppliers, distributors, logistics providers, traders, transport companies, forwarding agents, and their employees — are typically responsible for maintaining the original quality of these products. To ensure this, all parties involved in the distribution chain must adhere to the standards of good distribution practice.

Addressing the issue of counterfeit and substandard drugs

The guidelines emphasise procedures to ensure a safe, transparent, and secure distribution system, including product traceability throughout the supply chain.

They mandate procedures to ensure document traceability of received and distributed products to facilitate product recall.

All those involved in the drug supply chain must ensure that all pharmaceutical products are accompanied by documentation that allows for tracing throughout distribution channels, from the manufacturer to the importer, and ultimately to the entity responsible for selling or supplying the product to the patient or their agent.

Maintaining records to prevent spread of spurious drugs

Records, including expiry dates and batch numbers, must be part of a secure distribution documentation system that enables traceability. It is essential to ensure that dispatch records contain sufficient information to allow for the traceability of pharmaceutical products.

“Such records shall enable 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 must be recorded at the point of receipt to facilitate traceability,” the guidelines stated.

Additionally, the guidelines require that senior management of each entity be responsible for establishing, resourcing, implementing, and maintaining an effective quality system, with periodic meetings to review progress.

According to government data, India is home to approx 3,000 drug companies and 10,500 manufacturing units. The country’s drug manufacturing industry is expected to grow from its current value of $50 billion to $65 billion by the end of 2024 and is projected to reach $130 billion by 2030.