Need strong regulatory framework to monitor and implement D&C Act effectively: Experts

Stressing the need to strengthen the initiatives towards better implementation of the Drugs & Cosmetics (D&C) Act and Rules across the country, experts in the pharmacy field have asked the Drugs Controller General of India (DCGI) to take immediate steps towards reducing the problem of availability of prescription drugs without a prescription. To ensure safety and health of the patients further, they wanted the Centre to urgently work on a short and long term, multi-pronged national strategy by taking all the stakeholders into confidence.

This demand comes in the wake of high incidents of improper implementation of the D&C Act and Rules, especially lack of any uniform implementation as the extent and strictness of the same varies from the competence of the state drug licensing authorities (SLAs). This they fear is leading to malpractices like medical stores and pharmacies selling prescription only medicines without any prescription or proper prescription.

Raj Vaidya, an expert in this field, pointed out that in many instances it has been found that while medical stores or pharmacy shops do not dispense psychotropic medicines without a prescription, they dispense all other drugs without a prescription. At the same time, some do not dispense psychotropic medicines, antibiotics, and some other medicines having a misuse potential without a prescription, but dispense all other Rx drugs without a prescription. To make matters worse, some chemists do give at times the above, to clients they know without any prescription, at their discretion.

In his representation to the DCGI, Vaidya stressed that it has come into notice that some pharmacists and medical shops sell prescription medicines against telephonic orders and also conduct door delivery, while many have been found to be practically selling medicines without a prescriptions or without the presence of a pharmacist. Experts feel that while some state FDAs do make efforts to ensure strict control on sale of psychotropic medicines, many other crucial prescription medicines remain out of proper control. 

It is understood that the difficulty in controlling may be due to socio-economic reasons, but at the same time, misuse of medicines taking place because of sale without a prescription can also lead to health hazards even with medicines which are not for misuse or abuse. Ironically, people rampantly self-medicate anti-depressants, anti-hypertensives, anti-diabetics, NSAIDs, anti-ulcer medicines all of which are prescription medicines, because it was once previously prescribed to them or their family members. Vaidya pointed out that such actions are major cause of concern as it can lead to medication errors and ADRs.

He said, “Overnight change will not happen, and a sudden, knee-jerk implementation will only lead to boomerang and failure. Therefore, a gradual strategy will have to adopted, first tackling the drugs with more misuse potential, and step wise tackling of the others. There is an urgent need for massive awareness and education campaign amongst all the stakeholders and the public in particular, across the country to bring about the change. I sincerely hope that the Centre will take up the problem on a war footing, in the best interest of public health and safety.”

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2/10/2014 5:42:48 PM