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Correspondence

Indian Pediatr 2017;54: 691-692

Some Problems Associated with Generic Drugs

 

Yash Paul

Shah Hospital, Bani Park, Jaipur, Rajasthan, India.
Email: [email protected] 

 


Ministries of Health and Family Welfare of Government of India and the states, and Medical Council of India (MCI) have mandated that doctors shall prescribe generic drugs only and no branded drug should be prescribed. It is presumed that reputed pharmaceutical companies maintain stringent quality control of their products as their reputation is at stake. The same may also be true of unbranded products, but the market is currently flooded with spurious or sub-standard drugs [1]. It should be presumed that the Government machinery must have put in some mechanism to ensure that no spurious or sub-standard drug is manufactured any where in the country, so as to provide high quality drugs at low cost. I would like to bring to notice of the concerned authorities some of the problems that doctors could face:

1. The issue of different doses of drug (e.g., dextromethorphan, paracetamol) in formulations from different companies has been raised in past [2-4].

2. Phenylephrine is not available as single salt for oral consumption, but is available in majority of cases in combination with Chlorpheniramine maleate, cetrizine or levocetrizine. The combination of phenylephrine with other molecules manufactured by different pharmaceutical companies have different quantities of different ingredients. Interchange of brands may result in up to 100% lower or higher dose of drug that may be ineffective in one case or very high dose resulting in toxicity in other case. Doctors usually know the composition of the brand of drugs they prescribe, and it may be difficult to write names and quantity of all the ingredients needed for a particular patient, and would not be possible for the pharmacist to identify the required products.

3. Dicyclomine is not recommended for children below six months of age. For infantile colic in children below six months of age, Simethicon, Dil oil and Fennel oil are often prescribed. Some manufacturers market products containing dicyclomine in addition to the other ingredients meant for use in children aged <6 months; clinicians may face difficulty in prescribing these drugs.

4. Saccharomyces boulardii is recommended for antibiotic-associated diarrhea, and recommended dose is 5 billion spores once or twice a day. There are few preparations of S. boulardii with 5 billion spores in each dose. If the doctors are not permitted to prescribe S. boulardii as a brand preparation, they will have to write probiotic S. boulardii, 5 billion spores once or twice a day. As on date, no generic preparation has 5 billion spores of S. boulardii. Pharmacist can hand over any probiotic or pre-probiotic combination that has few million spores of S. boulardii, which may be 1/50th to 1/100th of the required quantity.

Such problems can occur with many other formulations, and are more likely to occur with formulations meant for children. The authorities should not only ensure the quality of drugs but also see that all similar drugs in the market are of uniform and rational formulations to avoid any mishap. These problems cannot be solved overnight. Till these issues are taken care of, the doctors should not be forced to prescribe only generic drugs.

References

1. Paul Y. Why should I not prescribe branded drugs? Indian J Medical Ethics. 2012;9:138.

2. Paul Y. Dextromethorphan: Problems with formulations. Indian Pediatr. 2014;51:1019.

3. Paul Y. Need for safe and doctor friendly drug formulations. Pharma Times. 2013;45:3-32.

4. Balasubramanian S, Ramesh V. Paracetamol – High strength formulations and toxicity. Indian Pediatr. 2014;51:839.

 

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