Sunday, May 4, 2014

A damning indictment of drug regulation in India - After a drug reaches the market

(This post is the last part of a series examining the functioning of India's drug regulatory authority, the CDSCO).

In the final part of their report, the Committee took a closer look at what happens once a drug is approved and reaches the market. For one thing, it needs a brand name. This is usually decided upon by the manufacturer and conveyed to the state authorities, which do not share this information with authorities in other states. As a result, asking for Lona at a chemist's shop could either get you low-sodium salt or the sedative clonazepam. Similarly, a drug with the brand name AZ could either be used to treat a worm infestation, a bacterial infection or anxiety - all very different medical indications. Such a situation is highly dangerous, since patients may end up taking the wrong medicine, with potentially serious consequences. There needs to be better coordination between State authorities, and the Committee recommended that "...a data bank of all branded pharmaceutical products along with their ingredients should be uploaded on the CDSCO website and regularly updated."

The Committee had earlier uncovered multiple instances where Post-Marketing Surveillance Reports (PSURs) had either been submitted incorrectly, or not at all. A total of 42 new drugs were randomly selected to check whether the rules regarding submissions of PSURs were being followed. Of these, PSURs for only 8 drugs were submitted. The Ministry claimed that 14 of these drugs were either new launches or not being sold and hence PSURs could be expected later. This turned out to be a lie since at least 2 of the 14 had been in the market long enough for manufacturers to submit PSURs. For another 17 drugs, the Ministry was unable to explain why there were no PSUR records.