Healthy Soch
Urgent need to take measures to stop marketing same drug under different brands and prices
New Delhi, March 13, 2018: As per a recent study, none of the five most commonly prescribed diabetes pills in India that combine metformin with other medicines have gone through rigorous testing meeting standards laid out by the WHO. In recent years, drug makers have increasingly been blending fixed doses of this medicine with fixed doses of other diabetes drugs that attack the disease differently.
The study, which appeared in BMJ Global Health, noted that the five top-selling fixed dose combination pills in India account for 500 different brands.
The findings of the study are concerning in light of the fact that clinical trials demonstrating safety and efficacy of these fixed dose combinations are neither publicly available or of low quality. It suggests that Indian patients taking these combinations should discuss with their clinicians before making a switching to a different agent.
Speaking about this, Padma Shri Awardee Dr K K Aggarwal, President Heart Care Foundation of India (HCFI) and Immediate Past National President Indian Medical Association (IMA), said, “Bioequivalence studies are conducted to establish that two medicines, normally the original patented drug and a generic version, have the same biological equivalence – that is, that they work the same way, to the same extent and for the same purpose. The most important characteristics of any drug is its Bioequivalence to the innovator product to prove its safety, clinical efficacy equivalence and cGMP compliance on continuous basis for sustainable supply. It is imperative that the government takes strong measures to strengthen the quality assurance infrastructure to the required level so that the quality of every batch of drugs is assured. Adequate regulatory manpower should also be deployed to enforce laws regarding drugs.
More than 95% of the drugs available in India are generic with no patent. They are available in the market with a generic name, trade name, or brand name from the same company. Being with no patent, over one thousand companies can market a single molecule. The word brand means a way to differentiate various generic drugs from each other.
Adding further, Dr Aggarwal, who is also the Vice President of CMAAO, said, “Doctors are committed to the welfare and safety of patients. Economy of drugs is only one dimension of the issue. There is a need to stop over-the-counter sale of prescription drugs without a prescription. Measures should be taken to disallow a company to market same drug in different prices under different brands.”
Medical Council of India Code of Medical ethics: 1.5 Use of Generic names of drugs: Every physician should, as far as possible, prescribe drugs with generic names and he / she shall ensure that there is a rational prescription and use of drugs. The interpretation is as follows.
- Use of Generic names of drugs: it’s not use of generic drugs
- Every physician should: the word SHOULD makes it non-binding
- As far as possible means to the best of his or her capacity
- Prescribe drugs with generic names: is not the same as prescribing generic drugs. It only means the name of the salt should also be written.
- Shall ensure that there is a rational prescription: Rational means prescription of drugs which are evidence based and or with informed consent.
- Rational use of drugs: means the same when dispensing.
