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Ramesh Shankar
Wednesday, January 31, 2018, 08:00 Hrs  [IST]

The Union Health Ministry is in the process of creating an exclusive schedule of over-the-counter drugs in the country. The drugs consultative committee of the ministry has already approved the creation of a separate OTC drug category by including medicines for minor illnesses such as fever, cough and cold and certain common allergies. For wider consultation, the ministry has formed a sub-committee comprising of five state drug controllers which will recommend the list of drugs which may be considered for marketing as OTC drugs along with conditions to be followed. This high powered panel has started examining the drugs marketed in the country vis-a-vis conditions for sale stipulated under various Schedules like H, H1, G, X and K. The new OTC category will be created in much the similar manner as Schedule H1 was created over three years ago which included habit forming drugs to be regulated in a proper manner. Now, these five state drug controllers will have a crucial role in framing the new category of OTC drugs.  Even though a separate category for OTC drugs is common in many countries, including developing and developed countries, in India allopathic drugs which are safe to be dispensed without prescription mostly fall under Schedule H and H1 and require a prescription. As per D&C Act 1940 and Rules 1945, these drugs should be sold against prescription only.

Of course, the intention of the government in creating an exclusive schedule of OTC drugs is good as it will improve accessibility and affordability of healthcare in the country, especially to the poor patients and those who reside in the remote areas. In India, a large percentage of people are still not in a position to bear the cost of treatment and the doctor's fee. Once schedule of OTC drugs comes out, patients will have no botheration of visiting doctors for treating common ailments.  A qualified pharmacist can then dispense OTC drugs for common ailments such as anti-allergies, antipyretic (for fever), antiemetic (for vomiting and nausea), muscle relaxants, decongestants (for cough and cold), anti-inflammatory, antacids, etc. But, the government should move with caution as a considerable section of patients in the country still require to be educated on the use and side-effects of OTC drugs. Though the OTC drugs are generally those that are effective for minor ailments and extremely safe to use, there should be some mechanism in place to prevent the indiscriminate sale of these drugs. For this purpose, the point-of-sale should be clearly defined and the labeling norms will have to be adequately revised to make it easier for consumers to read and understand its contents. Then there is the issue of similar sounding brand names with different drugs, which should also be addressed by the government before finalising a separate OTC drug category in the country.


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pradeep awasthi Feb 3, 2018 5:16 PM
India is a highly populated country,where still poor people resides in rural and remote areas,which have poor facilities for health care,due to high cost and poor accessibility.The most awaited decision of creating category of OTC division could be big boon for poor population,which are threatned of high cost of treatment.Though Union government is determined to set up,a panel of state controllers,to assess the remote areas for creating easy availability of Commonly manifested condition,such as flu,antiallergy,anti inflammatory and antiemetic products that can be freely dispensed by pharmacist without doctors rxions.But still this decision carries,lots of limitations in terms of side effects and administration,which need to be equally explained by pharmacist.
In addition to this,its favourable effects are yet to be reviewed by commite of state controllers.There is no doubt to the fact that OTC medicines are consumed without diagnosis and examination of doctors,Therefore
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