Bitter pills

Indian pharma industry must put its own house in order. It must be monitored stringently.

By: Editorial | Published:November 30, 2016 12:05 am

Twenty-seven commonly-used medicines in the country have failed quality tests in seven states. The medicines that include antibiotics, painkillers, cough syrups, anti-psychotic and anti-inflammatory drugs were found wanting on several counts, including false labelling and inadequate quantity of ingredients. The regulatory tests that began in March have incriminated 18 pharma majors. Alarmingly, only three of the medicine brands in question have been recalled from the market. The failure points to a longstanding problem: The Central Drug Standard Control Organisation reckons that inferior medicines constitute about five per cent of the drugs in the Indian market. Government surveys show this is an improvement compared with the mid-1990s when around 10 per cent of the drugs in the market failed quality tests. But other studies caution against optimism. For example, a 2014 study by ASSOCHAM estimated that around a fourth of the drugs sold are either substandard or counterfeit.

Ensuring quality drugs remains a problem in the absence of adequate regulations and shortage of drug inspectors and lab facilities to check purity. A drug inspector has the responsibility of inspecting various facilities including those producing allopathic drugs, homeopathic drugs, blood banks, even cosmetics. There has been no focus on specialists for each of these. The country consumes more than 385 billion medicines every year. But an ICRIER report of 2015 notes that there is no consolidated list of drug manufacturing outfits. Drug regulatory offices have been hamstrung by incomplete digitisation — in some cases, even incomplete computerisation. The inspection system is too lax to ensure quality control. In most cases, failure to comply with standards results in a short-term suspension of a manufacturer’s production licence — hardly an effective deterrent when manufacturers have several production units. Only in rare cases is the licence cancelled.

Substandard drugs prolong illness, cause antibiotic resistance, even death. The repeated administration of sub-therapeutic doses of anti-malaria medicines played a role in the proliferation of drug-resistant parasites. Poor quality antibiotics have been incriminated in the spread of tuberculosis. Internationally, India’s generic medicine industry has been questioned for compromising on product quality. The US Food and Drug Administration, for example, has banned medicines from at least 35 plants in the country. Last year, the EU banned 700 Indian drugs on grounds of quality. The country’s medicine industry has to put its house in order. The government should monitor it stringently.