India's top drug regulator, the Drugs Controller General of India (DCGI), has introduced standard operating procedures and guidelines to enhance product trackability throughout the supply chain. This enterprise addresses the growing issue of counterfeit and substandard medicines, according to Livemint. The new good-distribution practices aim to tackle the notable challenge of ensuring trackability, undermined by deficient documentation within the distribution network. Improved trackability will be important for pinpointing where contamination or counterfeit drugs enter the supply chain.

This enterprise is crucial as the Indian pharmaceutical industry faces international scrutiny after averment linked fake cough syrups made in India to the deaths of children in Gambia, Cameroon, and Uzbekistan. In a June meeting of the DCGI’s drugs consultative committee, it was clear that it could incorporate the good distribution practices into the Drugs and Cosmetics Rules, 1945, as an official Schedule. The meeting disclosed that the voluntary nature of current guidelines has led to insufficient assurance about maintaining proper drug storage conditions during freightage to wholesalers and retailers by manufacturers.

The draft guidelines for good distribution practices have been aligned with World Health Organization (WHO) standards, and shareholders have been given 30 days to offer responses and proposals before the rules are finalized. The Drugs & Cosmetics Act of 1940, along with the Drugs & Cosmetics Rules of 1945, outlines the essentials for the sale, stocking, exhibition, or supply of drugs across India.

The edition instructions state that everyone involved in handling, storing, and distributing pharmaceutical products - including manufacturers, wholesalers, brokers, suppliers, distributors, logistics providers, traders, transport companies, forwarding agents, and their employees - is generally responsible for conserving the original quality of these products. To achieve this, all dealers in the issuing chain must fall in with good distribution practice standards.

Tackling the Problem of Counterfeit and Substandard Medications

The edition spotlighted the formalities to support a safe, transparent, and reliable distribution system, highlighting product trackability throughout the supply chain. They require paper  trackability for both received and distributed products to aid in product recalls. 

Everybody in the drug supply chain must make sure that all pharmaceutical products are escorted by documentation accessing trackability from the producer to the importer, and ultimately to the organization answerable for selling or supplying the product to the patient or their nominative.

Keeping Records to Prevent the Distribution of Counterfeit Drugs

Records, including expiry dates and batch numbers, must be part of securing the distribution documentation system that ensures trackability. It is a major product that wipes out the records and provides sufficient details to track pharmaceutical products. 

According to the instructions, such documentation should sanction the recall of a product batch if it's needed and help in inquiring about counterfeit or possible counterfeit drugs. The batch number and expiry date ofc products must be written down upon receipt to support trackability.

Furthermore, the instructions direct that senior management at each organization be overseen for initiating, resourcing, implementing, and maintaining a quality system, with regular meetings to review progress.

Government data indicates that India has approximately 3,000 drug companies and 10,500 manufacturing units. The country's drug manufacturing sector is expected to grow from its current USD 50 billion valuation to $65 billion by the end of 2024 and is projected to reach USD 130 billion by 2030.