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The Union Health Ministry is well on path to create an exclusive schedule of over-the-counter drugs in the country. The Drugs Consultative Committee of the ministry has recently formed a new three-member sub-committee under the chairmanship of Haryana state drugs controller to define the OTC drugs that can be sold in the country without prescriptions and put in place a regulatory framework for these medications. Even though a separate category of OTC drugs are 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. The newly formed sub-committee will now review an earlier report on this issue submitted by a group of experts that details various aspects of OTC drug trade including their definition, initial list of medicines, manufacturing and labelling regulations, classification and approval process. Early last year, the ministry had formed a sub-committee comprising of five state drug controllers to recommend the list of drugs which should be considered for marketing as OTC drugs along with conditions to be followed. After thoroughly 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 panel submitted its recommendations to the ministry. Now the new sub-committee will examine these recommendations further and a new OTC category will be created in much the same manner as Schedule H1 was created some time ago which included habit forming drugs to be regulated in a proper manner.
Of course, there is a need to create a robust regulatory framework for OTC medicines in the country by including a separate schedule in the Drugs and Cosmetics Act as that 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 as a qualified pharmacist will then be empowered to dispense OTC drugs for common ailments. Once the sub-committee report is finalised, the ministry will introduce a new category of OTC medicines for common ailments such as anti-allergy, antipyretic and anti-emetic drugs that can be dispensed by pharmacists without a prescription. The list may also include muscle relaxants, decongestants, anti-inflammatory drugs, antacids, external preparations for skin and hormonal contraceptives. 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. So, the three-member panel, which also includes Karnataka state drugs controller and a Deputy Drug Controller at Central Drugs Standard Control Organisation, will have a crucial role in framing the new category of OTC drugs.
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