Unethical practice of dispensing cheap substitutes of low molecular weight heparin to patients, suffering from cardiac arrest, is found to be flourishing in several parts of India. These products are being sold at four times the actual cost by evading local quality and regulatory regulations and protocols.
The practice has become rampant across corporate hospital pharmacies in the country seriously endangering the patient safety.
The low molecular weight heparin marketed under the trade names Clexane, among others is an anticoagulant used to prevent and treat deep vein thrombosis or pulmonary embolism, and is given as a subcutaneous injection. Its use is evolving in acute coronary syndromes (ACS). Clexane originally manufactured by Sanofi, the product is derived from the intestinal mucosa of pigs and is currently under price control. It's current price fixed by NPPA is Rs.439.39 and is available in 40 mg and 60 mg strengths.
Although a Schedule H drug, meant to be sold against a prescription, it is illegally sold at hospital pharmacies with the nexus between local pharma companies, hospital pharmacies and their designated stockists to rake in profits. A hospital on an average sells around 3000 units in prefilled syringes to gullible patients.
There are around 80 local pharma brands for this product which is being procured at a nominal cost of Rs.100 from the stockists or even retail pharmacies and sold to the patients at a price determined by the management of the hospitals in connivance with authorised distributors of local pharma companies.
According to sources, an important life saving drug like Heparin which has been capped at Rs.439.39 as per the DPCO can translate into huge profits for the hospitals. Patient safety is at stake because a sub-standard or a low quality substitute of the drug can lead to excessive bleeding when injected sub-cutaneously. But the hospitals are averse to the idea of patient safety and most often find an escape route by wrongly misreporting in case of an adverse reaction or death of the patient.
A comparative evaluation study on price and quality of generic drugs and their reputed branded generics done by a team of experts found that they were identical in terms of identification, uniformity of weight, assay, uniformity of contents and dissolution.
Most often it has been observed that sound alike look alike drugs are consumed by patients because of the growing nexus and the following cut practice which leads to unhealthy competition. The onus therefore lies with regulators to ensure that quality control protocols and regulatory compliance is enforced and adhered to. It has therefore been given to understand that quality control protocols and regulatory compliances are put at stake in order to sell the drug endangering patient's life.
Growing at a compounded annual growth rate (CAGR) of about 25%, the fake drugs market in India is likely to cross US$ 10 billion mark by 2017 from the current level of about worth US$ 4.25 billion, according to an ASSOCHAM analysis.