Drugs Controller General of India (DCGI) has called on the distributors and retailers across the pharma supply chain to evolve and adopt strategies to ensure that drugs are procured from the authorised channels with proper records maintained on its source and supply. The regulator has also mandated to the pharmacy trade to share their action plan on the same.

The move by DCGI is based on the massive exercise of the National Survey of spurious and NSQ drugs that was released in February 2017 which identified the certain problems related to quality of medicines in the country.

The regulator highlighted that retailers are the first point of call for the consumers to get their supply of safe and quality drugs. They must ensure that drugs are procured from authorised channels and maintain proper records of procurement to track and trace the movement of drugs from the manufacturer to the user. Retailers and distributors should modernise and digitize the mechanism of procurement and inventory control of all their operations and ensure presence of qualified pharmacists to dispense drugs as per the norms.

Further the DCGI indicated that the retailers should ensure storage conditions for drugs are in compliance with the labelling provisions of the law and the quality is maintained throughout the shelf life.

There is also considerable importance in training of all personnel involved in distribution and dispensing activities on the requirements of Good Distribution Practises(GDP) including documentation.

Retailers should quarantine and promptly notify regulators about a drug that has been identified as suspect which means if it is spurious or not of standard quality or potentially harmful. During instances of product recall, the retailers and distributors must cooperate with the regulatory agencies, stated the DCGI note.

In addition for the system of third party inspections of retail outlets including hospitals, dispensaries, wellness centres should be put in place systems to ensure adherence to the requirement of GDP and Good Storage Practices (GSD).

Appreciating the move by DCGI, JB Chowhan, chairman, Vardhaman Health Specialities said this was long over due for the pharmacy trade sector which is the point for quality drugs access for patients.

In the case of Bengaluru-based Vardhaman Health Specialities, which according to the company is the first WHO (GSDP) certified distribution company, that sought the certification in 1988, Chowhan has now made a representation to the DCGI to extend its expertise GDP and GSP to ensure that quality and safe drugs are available round the clock.

“We have the know-how and the advanced infrastructure to offer any distributor and retailer with the cold chain facility and logistics for any time access to drugs. During the implementation of GSP and GDP, we encountered several obstacles like loss in business for want of reciprocal cooperation from the stakeholders. The delays did hit our profit margin. Nevertheless it has been a learning curve. Now with the rapid transformation, we are keen to chip in our inputs to the pharma distributors and retailers in the country,” he added.