Govt sanctions Rs 1,850 cr to ensure better drug monitoring systems

India is stepping up efforts to improve its quality systems and ensure better compliance in drugs and medical devices. Apart from hiring manpower, the Central Drugs Standard Control Organization (CDSCO) will also invest in developing the Sugam portal to list all drugs made in the country, and its manufacturer details along with licences. This will make it easier to track the supply chain of drugs in India.

Speaking at an event in Mumbai, the Drugs Controller General of India V G Somani said the government has already earmarked Rs 1,850 crore for the project that will primarily look at strengthening the quality systems for drugs and medical devices.

A significant share of this money will go into upgrading the Sugam portal — the e-governance solution for CDSCO. The data related to each and every drug manufactured in the country, along with its dosage forms, would have to be registered by the manufacturer on the website. Manufacturers will also have to upload their manufacturing licences on the portal.

The CDSCO would thus, have the entire information at its fingertips. There are plans to introduce an online procedure to trace the supply chain of drugs on the Sugam portal. This will prove helpful to recall drugs in case of crisis — for example, the recent cough syrup case that led to the deaths of nine children in Jammu & Kashmir. The government can take speedier measures when it has better monitoring and tracing systems in place.

Somani said the CDSCO is working to improve the monitoring of drugs that are made and sold across the country. The manufacturing plant of Himachal Pradesh-based drugmaker Digital Vision has been shut and 50,000 bottles of the cough syrup recalled. Somani said an investigation is on and a report is expected next week.

The CDSCO and the US Food and Drug Administration signed a memorandum of understanding this week to collaborate on capacity-building for quality of medical devices.

Meanwhile, India will soon join the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, an initiative that brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.

“The regulators will discuss and agree upon the standards of inspection,” said Somani. Harmonisation is difficult among countries as there are differences between the regulations (in terms of legal framework, etc).

India has also been contemplating joining the Pharmaceutical Inspection Co-operation Scheme (PIC/S), an international instrument meant to improve cooperation in good manufacturing practices between countries and regulatory authorities. However, the World Health Organization has cautioned low- and medium-income countries like India against joining the PIC/S, keeping in mind accessibility and affordability of drugs.