This editorial provides a balanced and neutral perspective of the debate regarding use of brand-name versus generic medicines, from an Indian endocrine point of view. It helps stakeholders arrive at appropriate decisions, using a process of informed and shared decision-making [1].
The authors define nomenclature of drugs, including chemical, brand and non-proprietary names. They compare brand-name and generic drugs in terms of quality, cost, efficacy and safety. Generics are expected to be of equal quality, efficacy and safety, while offering cost benefits compared to originator molecules. This is achieved by following strict regulatory requirements, including in vitro dissolution and in vivo bioavailability and bioequivalence testing, and ensuring good manufacturing practices (GMP) are followed.
In India, the state authorities regulate the manufacture, sale and distribution of drugs. While central authorities approve new drugs and clinical trials, set standards, control the import of drugs, coordinate State Drugs Control Organizations and ensure uniformity in the enforcement of drug-related legislation.
Drug testing laboratories, both central and regional, monitor drug samples to ensure that standards are maintained. However, limited manpower and resources often mean that the regulatory authorities are unable to ensure adequate testing at regular intervals. This does not allow them to fulfill their mandate of ensuring the quality of drugs. Substandard, spurious and counterfeit medicines continue to be available.
The Medical Council of India (MCI) encourages rational prescription and use of drugs, while promoting prescription of drugs with generic names. This directive shifts the onus of selecting a brand-name drug from the physician to the pharmacist, as most Indian drugs are generics, albeit marketed under different trade names. Though theoretically welcome, this rule does not hold practical utility, as the quality of all drugs cannot be guaranteed under the existing regulatory mechanisms.
In endocrinology, especially, the use of modified release formulations and hormones with specific bioavailability is common. Brand-name drugs should therefore be switched only after careful evaluation by the physician. The solution is to strengthen the drug quality control apparatus of the country, by opening new laboratories, as well as increasing the capacity of existing laboratories. This will ensure that GMP are followed by all manufacturers, who must submit in-house quality control reports for each batch of medicines. Until this becomes the case, physicians should practice shared, and informed, decision-making when prescribing medications and should involve both pharmacists and patients.
Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.
Abstracted by Sanjay Kalra of the Department of Endocrinology, BRIDE Hospital, Karnal, Haryana, India.
Editor’s comment
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Myths, questions, facts about generic drugs in the EU
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Reference
1. Dhamija P, Sharma PK, Kalra S. Only generics (drugs/names): Is India ready? Indian J Endocrinol Metab. 2015;19(5):541-5.
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