India to have better drug monitoring systems soon
India is stepping up its efforts to improve its quality systems and ensure better compliance in drugs as well as medical devices.
Apart from hiring manpower, the Central Drugs Standards Control Organization (CDSCO) would also invest in developing the Sugam portal that will list all the drugs made in the country, and its manufacturer details along with the licenses. This would make it easier to track the supply chain of drugs in India.
Speaking here at an event the Drug Controller General of India V G Somani said that the government has already earmarked ~1,850 crore for the project that will primarily look at strengthening the quality systems for drugs and medical devices.
A significant portion of this money would go into upgrading the SUGAM portal, the e-governance solution for CDSCO. 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 would also have to upload their manufacturing licenses on the portal.
The CDSCO would thus have the entire information at its finger tips. There are plans to introduce an online procedure to trace the supply chain of drugs on the SUGAM portal. This would prove helpful to recall drugs in case of any crisis, for example, the recent cough syrup case that led to death of nine children in Jammu and Kashmir. Government can take speedier measures when it has a better monitoring and tracing system in place.
Somani said that the CDSCO is working to improve the monitoring of drugs that are made and sold across the country. As such the manufacturing plant (of Himachal Pradesh based drug maker Digital Vision) has been shut down and 50,000 bottles of cough syrup been recalled. Somani informed that an investigation is on and that a report is expected next week.
The CDSCO and the US Food and Drug Administration (USFDA) signed a memorandum of understanding this week to collaborate on capacity building for quality of medical devices.
Meanwhile, India will soon join the The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), an initiative that brings together regulatory authorities and 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,” Somani said. Harmonisation is difficult amongst various countries as there are differences between the regulations (in terms of legal framework etc).