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.

Of the submitted PSURs, the Committee found that most of them were generic and did not specifically apply to India. Some of them were also not submitted in the format required by Indian law. Such violations of the rules regarding PSUR submissions means that adverse events, if any, are highly unlikely to be detected and reported to the authorities. This reinforces the point that Indian authorities are not equipped to make informed decisions about the safety of new or marketed drugs, and must rely on data from countries with more stringent regulatory requirements for such information. The danger in this situation is that side effects specific to Indian ethnic groups are likely to be missed altogether. In addition, information on drugs that are currently being marketed should be regularly updated to reflect global changes in efficacy and safety.

A very interesting point raised in this report is the issue of spurious drugs in India. Some drugs may be classified as "Not of Standard Quality" due to major or minor technical reasons. Of particular concern are those cases where the active ingredient is not present in the stated amount. Problems may also arise due to improper supply chain and storage methods, such as letting temperature sensitive medicines sit on a chemist's shelf rather than in a refrigerator. Traders are also allowed to directly import and supply certain drugs (apparently for tax reasons), and there is no way of checking these drugs for quality since they do not enter the direct retail chain.

Another serious issue that the Committee tackles is the perception that there is a high percentage of fake and spurious drugs in the Indian market. Indian drug makers complained that much of this was misinformation spread by (as they allege) foreign drug manufacturers to undercut Indian companies which otherwise are successful in both domestic and international markets. One of the ways in which they do this is to exploit the fact that the word "counterfeit" in relation to drugs has different legal meanings in the West and in India. In the West, an Indian drug can be called counterfeit if it is a generic version of a patented drug manufactured without approval from the original inventor, even if there is no valid patent for the drug in India. These semantic loopholes are exploited to create the impression that Indian medicines are of poor quality, whereas "According to a study by the CDSCO, the prevalence of spurious drugs in India is less than 0.5 per cent as against the allegations by MNCs of 25-30 per cent". Such percentages do not justify the introduction of costly tracking measures, such as barcodes, which will only increase costs without providing much benefit to consumers.

If the CDSCO receives reports of any batch of drugs being sub-standard in quality, it recommends that the information be immediately publicised through press releases and paid advertisements as well as being uploaded to the CDSCO website. It is noteworthy that the state authorities in Maharashtra and Kerala have taken the initiative to upload information about spurious and sub-standard drugs to their website on a monthly basis, and it is suggested that other states follow suit.

Unlike in the US, prescription drugs in India cannot be the subject of direct advertisements to the public. Some manufacturers have violated this rule, and the Committee strongly recommends that the manufacturers of these drugs be slapped with the appropriate penalties. A longer-term solution will be to strengthen the laws regarding these issues, which are currently not stringent enough.

The Committee has also found that package inserts were extremely consumer-unfriendly; they were highly technical and meant to be used by medical practitioners rather than the average consumer. Such package inserts serve no purpose since they would only confuse people, while failing to provide important information about dosing and side effects in simple, non-technical language. The Committee has suggested the development of an online database, "a system where patients can get unbiased information on drugs at the click of the mouse in any language."

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