Recently the Government of India and the Medical Council of India have called upon doctors to prescribe generic drugs or face action. We share our experience of prescribing by generic name- zinc sulphate syrup to a diarrhea patient, following which there was difficulty in procurement because either the pharmacist was unaware, drug unavailable, a substitute offered, branded drug choice given or informed not to buy for its doubtful potency and safety. The patient’s parents appeared confused and at loss about how, where and whether to buy this ‘new’ medicine. This made us wonder whether prescribing generics really is a smart initiative.

Doctors appear hesitant or reluctant to use generics and they question their quality. Considerable amount of research in the area of equivalence of generic medicines has shown that generics can be used safely with no negative clinical impact [1-3]. These studies originate from countries with stringent regulations for generic drugs. However, to extrapolate these data to Indian scenario would not be appropriate as the regulatory environment prevailing in India is not robust raising questions whether the generics are as effective as branded drugs.

The drug regulatory system in the country suffers from inadequate manpower and infrastructure, ill- equipped drug-testing laboratories, lacks accurate drug information and database, has serious shortcomings in Centre-State coordination in the implementation of Drugs and Cosmetics Act and Rules, and is urgently in need of strengthening in terms of transparency and accountability [4]. Though actions have been initiated, they are far from satisfactory.

Asking doctors to prescribe generic drugs does not appear to be a rational prescription in the current healthcare system. Policy makers must take a holistic approach ensuring availability of quality generic drugs, raise awareness amongst patients, pharmacist and healthcare providers about advantages of these drugs, enforce stringent quality control measures at all levels of pharmaceutical chain, and roll out a time bound strategy in a phased manner. Ensuring drug safety and quality remains a top priority. Thoughtless implementation of policy is likely to lead to chaos, confusion, or worst a tragedy essentially preventable.

1. Tattevin P, Crémieux A-C, Rabaud C, Gauzit R. Efficacy and quality of antibacterial generic products approved for human use: A systematic review. Clin Infect Dis. 2014;58:458–69.

2. Manzoli L, Flacco ME, Boccia S, D’Andrea E, Panic N, Marzuillo C, et al. Generic versus brand-name drugs used in cardiovascular diseases. Eur J Epidemiol. 2016;31:351-68.

3. Talati R, Scholle JM, Phung OP, Baker EL, Baker WL, Ashaye A, et al. Efficacy and safety of innovator versus generic drugs in patients with epilepsy: A systematic review. Pharmacotherapy. 2012;32:314-22