Healthcare in India is a joke. Medicines that have been banned in several countries were till recently available in the Indian market. Procuring most of these medicines wouldn’t even need a prescription. The government claims availability of such over-the-counter drugs is putting our very lives in a big threat.
Taking a stock of this deplorable condition in India, the health ministry recently banned 344 fixed dose combinations (FDCs) drugs. In a layman’s term, FDCs are created by rolling two or more active drugs into a single dosage. In itself, combination drugs are not harmful. They are used across the globe to improve patients’ compliance, because let us admit, when we fall sick, taking just one pill is more convenient rather than popping several pills.
India is one of the world’s largest markets for fixed dose combination (FDC) drugs that make up almost half the market share. It was made mandatory for FDCs to get an approval from the Central Drugs Standard Control Organisaton (CDSCO) since 1961.
It’s the inconsistent and slack Indian drug laws that have created a huge mess in the health care sector. Reports say there are hundreds of unchecked drugs that enter the medicine market; medicine-makers, both big and small, play a game here. Instead of getting their medicines approved by the more stringent central regulators, the pharmaceutical companies knock the doors of individual state regulators. That way, their job becomes easier.
Although the ministry has not yet released any specific list of the FDCs, certain popular medicines, such as Vicks Action 500, Benadryl, Corex and Phensedyl have been banned. The ministry says the excessive use of these cough drugs might cause anti-microbial resistance and in extreme case, cause organ-failure due to high toxicity.
Pharma giants Proctor and Gamble (Action 500), Pfizer (Corex), and Abbot (Phensedyl) have already stopped manufacturing the banned medicines. Phensedyl is banned in the United States, United Kingdom, Germany, France, Japan and Australia.
Banned Phensedyl accounts for about one third of the Indian cough syrup market, and its sales are estimated to make up more than 3% of Abbott’s $1-billion India revenue. Corex garnered sales of Rs 176 crore in the nine-month period that ended on December last year.
Phensedyl and Corex contain Codeine phosphate, a highly addictive opium-based composition. It is misused by youngsters as a cheap and easily available alternative for drugs. While Corex and Phensedyl are the most popular among addicted youths, in contrast, Glycodin, a cough syrup containing dextromethorphan, a safe constituent approved by the World Health Organisation, does not sell as much.
FDC of the popular Nimesulide also has been banned because of its adverse side-effects on the liver. Nise, a Nimesulide, is one of the top-selling painkillers in India manufactured by Dr Reddy’s. It’s alarming to know that this medicine is not permitted in America and is not approved for use in Britain, Canada, Sweden, Denmark, Australia, New Zealand, Japan and 168 other countries.
Dr CM Gullati, editor of the Monthly Index of Medical Specialities (MIMS) says that around 90% of the medicines are irrational. The health ministry had issued a public notice in 2013, asking drug manufacturers to declare fixed dose combination medicines.
Gulati says, “Out of about 15,000 pharma units that are active in India, only 6,600 responded, thinking we may not take action.” Sadly, this statement sums up the attitude of several medicine-makers in India, because, “not taking action” is the norm here. But the firms who chose to ignore the ministry’s notice, are in hot soup. “Now that we have taken action, they are rushing to courts for respite,” added the health ministry official.
The Narcotics Control Bureau (NCB) in 2010 stated that in the north-east alone, police and security personnel hauled illegal bottles of cough syrups worth over Rs 20 lakh a month. That was six years back. By now, the figures must have multiplied by many times.
It’s sad that India is waking up to the hazards now. But then going by the old ways, the ban might just fizzle out if the pharmaceutical firms drag the case to the court. A similar thing had happened in 2007, when several drugs were banned.