Ever wondered why the branded Crocin takes less time to rid you of your headache or fever than its generic version paracetamol? Because though the government pushes hard to popularise generic drugs, Indian pharma companies are not manufacturing medicines according to international standards. This is while the government is mulling making it mandatory for doctors to mention the generic names of branded medicines in prescriptions.
Meanwhile, the government maintains that its policy to promote generic drugs will include only those manufacturers who comply with the World Health Organisation guidelines. “We have announced the setting up of 3,000 generic stores across the capital. The next step is to make at least one Jan Aushadhi store compulsory in all top private hospitals of the country,” says Chemicals and Fertilisers Minister Ananth Kumar.
The proposal has been sent to the Union Health Ministry, which has agreed to it in-principle and is holding consultations with private hospitals.
India has a four-tier system of guidelines for drug manufacturing. The Drug Controller General of India (DCGI) has set up the Good Manufacturing Practices (GMP) for pharmaceutical companies. Most generic medicines are manufactured by just meeting basic GMP guidelines. They are only required to do so. Branded medicines get progressively expensive according to further tiers—WHO, European and the US Food and Drugs Administrator. In India, generic drugs are made by both branded and bulk drugs manufacturers, who sell them without the company label. Hence they are cheaper than patented drugs as well.
In India, generic drugs are made by both branded and bulk drugs manufacturers, who sell them without the company label. Hence they are cheaper than patented drugs.
“The problem lies not in the chemical composition of the drugs, but in factors like the quality of water used as solvent or the packaging of tablets,” Dr Rakesh Garg of the B R Ambedkar Cancer Institute, AIIMS, told The Sunday Standard. He added, “While we would like manufacturers to be a bit more humane while making generic medicines, it is also true that the government guidelines need to be upgraded and made more stringent.”
According to Rajiv Nath of the Association of Indian Medical Devices Industry, the fact that the government itself is talking of procuring generics from WHO-compliant manufacturers speaks volumes about the need for upgraded DCGI guidelines in manufacture of pharmaceuticals.