India has had a long tryst with substandard drugs. These drugs are less effective, cause the disease to last longer, and most dangerously, can cause antibacterial resistance.
According to an Indian Express report earlier in December, Mozambique had raised concerns about quality of medicines that were exported from India. Shortly before that, the drug regulator in Vietnam had blacklisted 39 Indian pharmaceutical companies for exporting poor quality drugs.
A report by IndiaSpend earlier this year revealed that one in seven Indian drugs are found to be substandard. The implications of this – in a country where over 50 percent of the total health expenditure is an "out-of-pocket cost burden on the people" – are dangerous and more often than not, fatal.
When pushed into a corner, the Indian pharma industry seems to have four key strategies to fall back on.
1. The Miffed Foreign Regulator
The primary strategy, according to an Indian Express report, is to play victim. It's used largely against foreign regulators who call Indian pharma companies out on quality. At the core of this strategy is the allegation that the foreign regulators’ action is in response to India's tough IP laws which often irk the Western pharma industry.
2. Blame It on Storage Conditions
The argument made here is that the drug which has been declared substandard didn't get appropriate storage after it was released by the manufacturer.
In hot and humid climates like India, it is argued that the drug mutates if not stored properly and is bound to fail a quality check.
This allegation, however, has no standing ground, as the Indian Express report points out, because globally accepted regulatory standards are made keeping in mind the specific climatic conditions of the countries.
India, for example, is classified under Zone IV countries, and the drugs meant for India are expected to survive in high temperatures. The truth is that Indian manufacturers don’t necessarily “test for stability” before the drugs are shipped out.
3. But, It Wasn't Even Us!
A third strategy employed is to say that the drug sample was never even manufactured by the company under scrutiny, and was in fact counterfeited by seedy, disreputable manufacturers.
It's tricky to check if these claims are true, as regulators often don't reveal adequate information. It would, however, be more profitable and less risky for counterfeiters to rip off Western brands that would get them a much higher price in the market.
4. To Cry Foul and Scare off Allegations
Pharma companies often resort to filing defamation lawsuits to wriggle out of these situations.
The Indian Express quotes an incident in 2011, where Dr Chander Gulati, Delhi-based editor of Monthly Index of Medical Specialities, faced a criminal defamation lawsuit filed by Lundenbeck India Pvt Ltd, for writing about a controversial drug sold by the company in India.
The following year, in the 59th report of the Parliamentary Standing Committee on Health, the same drug was red-flagged.
Currently there are 36 drug regulators in India that continuously conduct quality checks. There is, however, no nation-wide drug recall system, neither are there rules mandating companies to recall substandard drug batches from the market. There are reports however, that the government is going to amend the Drug and Cosmetics Rules 1945.
The situation has persisted for so long as government after government and public health activists continue to advocate for the pharma industry, arguing that the drugs are affordable. But if that affordable medication comes at the cost of prolonged diseases, drug resistance and even death – we need to evaluate our priorities.
(With inputs from The Indian Express, IndiaSpend)
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