1. Mapping post-marketing surveillance of pharmaceuticals in India

Mapping post-marketing surveillance of pharmaceuticals in India

Ensuring safe and quality medicines requires continuous monitoring by regulators and manufacturers alike.

By: and | Updated: December 21, 2015 4:53 AM

Ensuring safe and quality medicines requires continuous monitoring by regulators and manufacturers alike. While due care needs to be taken at the stage of product development and manufacturing, strong mechanisms are required even after the product has entered distribution networks. These include detection and assessment of adverse effects or any other drug-related problem that can be monitored through a pharmacovigilance programme in order to ensure patient safety with regard to the use of medicines.

The Pharmacovigilance Programme of India (PvPI) was launched in 2010 for monitoring adverse drug reaction (ADR) or adverse drug event (ADE). It functions through reporting of adverse reactions/events by health professionals and the data collected is used to analyse the benefit-risk ratio of marketed medications and recommend informed regulatory interventions. Its mandate includes the detection of medicines of substandard quality as well as prescribing, dispensing and administration errors. Independent of this system, drug alerts play a major role in post-marketing surveillance of medicines. Drug inspectors, both at the Centre and state levels, regularly sample drugs that are then tested at the government laboratories. A list is generated of those drugs that fail one or more of these tests. Since 2012, the Central Drugs Standard Control Organisation (CDSCO) has been posting such lists on its website on a monthly basis. However, not all states seem to have kept up with this practice, and state-level information is either not available or available in an incomplete manner on their respective websites.

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The lack of comprehensive data across states makes it difficult to map precise state-specific problems and, thus, solutions needed to correct them. However, a quick analysis of the CDSCO data provides some insights. A study by the authors finds that the number of not of standard quality drugs (NSQ) has almost doubled between 2013 and 2014, which can be attributed to either a larger number of samples collected in the later year or the improved testing procedures used on these samples. Upon analysing the drug alerts on the basis of their manufacturing origins (see chart), it can be seen that a large number of samples were manufactured in Himachal Pradesh and Uttarakhand. The case of Himachal Pradesh comes across as a particularly interesting one, given that it is one of the largest pharmaceutical manufacturing hubs in the country but has an inspectorate strength of 14.

There is limited data availability and this creates challenges understanding the true nature of the problem and designing effective solutions for the same. First, the data on drug alerts has reportedly been made available by a number of states through the Xtended Licensing and Laboratory Node (XLN) platform; however, it is not yet available for public view. Moreover, the restricted outreach of PvPI has led to under-reporting to ADRs, and whatever data is collected is currently not shared with concerned companies or even the public at large. Finally, the data that has been made public by the CDSCO seems rather incomplete, since there is no way of knowing the actions that have been initiated for NSQ drugs. While there are elaborate guidelines available on the CDSCO website with respect to drug recalls, any lists of effectively recalled drugs seem amiss. It should be noted that carrying out recalls is not simple, and difficulties arise when they have to be recalled at the level of the retailer. This is further complicated if a laboratory report identifying a faulty product takes three to four months to process—by then, a large portion of the batch may have already been consumed in the market, especially if they are fast-moving products.

Issues linked with drug recalls are global in nature and have been major concerns in developed regions such as the US and EU, where these have led to market shortages. Product recalls are tricky for individual companies who often weigh the costs versus the benefits of carrying out the recall, as they are expensive, tedious and often have damaging effects on company reputation.

Having said that, the mechanisms for post-marketing surveillance in some developed countries are stringent and well in place. The UK’s Yellow Card Scheme allows any person—a health professional, pharmacist or consumer—to report a suspected product via phone, email or an online form. In China, the ADR reporting is based on 11 criteria used to identify the seriousness of the case, and quality issues with a particular drug are identified through a cluster-based approach—if they are being repeatedly reported from the same source—which are then reported to the China Food and Drug Administration. India could draw lessons and set up an integrated system of drug alerts with well-functioning adverse event reporting mechanisms. But since most mechanisms are already in place, only their strengthening and integration with one another needs to be looked into. Strong post-marketing surveillance are vital means for providing assurance to consumers that the system is well-equipped to catch any errors in the safety profile of a drug well in time.

Authors are research associates, Health Policy Initiative, Indian Council for Research on International Economic Relations (ICRIER)

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