Pharmacists want regulators to strictly implement Schedule K (5) of D&C Act

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Pharmacists across the country want the drug regulators to take a uniform stand while ensuring the implementation of different provisions of the Drugs and Cosmetics (D&C) Act. This demand comes in the wake of rising frustration among the pharmacy community over the two faced approach the drug regulators have been displaying while implementing Schedule K, which deals with monitoring and controlling the practice of registered medical practitioners engaged in stocking and dispensing of medicines directly to the patients without licence.

Experts claim that while the regulators have been taking strict action towards monitoring the work of the pharmacy and chemists shops, same enthusiasm is seldom displayed while implementing Schedule K (5) of the Act. Under Schedule K (5), doctors are allowed to dispense medicines in their clinics only under certain conditions like emergency situation. In fact, according to Raj Vaidya, a community pharmacist and an expert in this field, even while stocking medicines doctors cannot stock more than required amount of medicines, as per the law, which however is clearly not monitored by the drug regulators.

He said that due to this lackadaisical attitude of the monitoring authority, doctors across the country are seen to be rampantly flouting the provisions in this Schedule by dispensing medicines indiscriminately at varied prices. “Schedule K (5) was included in the Act at a time when there was a serious shortage of pharmacists and medical shops in the country, which was threatening the availability of lifesaving medicines for the patients. However with changing times the situation has also changed. Today we will find medical stores and pharmacy shops in every nook and corner of our place. Hence we feel that Schedule K (5) should be omitted from the Act as there is no requirement for this provision today,” Vaidya stressed.

He further pointed out that since stocking and dispensing medicines is a professional duty of a pharmacist with valid license, only a pharmacist should be given the exclusive right to do the same. Pharmacists across the country through representative bodies like Indian Pharmaceutical Association (IPA) have been sending representation to the health ministry and the DTAB demanding the omission of this particular provision from the Act. While the issue is still open for debate, Vaidya hopes that considering the interest of the patients at large and keeping the essence of the Act, the regulators should ensure strict implementation of this provision, to ensure that the doctors are not violating the provisions of the D&C Act by running parallel pharmacies without license to sell drugs.

Source: PharmBiz

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