The Karnataka drugs controller Raghurama Bhandary has warned the pharmacy outlets and the pharma companies of strict action if they failed to comply Rule 65 (11-A) of the Drugs and Cosmetic Rules under which 46 drugs have been put under special category (Schedule H1) for which the pharmacists are mandated to maintain a separate register during sale of such medicines.

The Rule 65 (11-A) became effective from March 1, 2014, and was introduced by the union health ministry to monitor the sale of 46 drugs comprising antibiotics, anti-TB drugs and habit forming drugs.

Further, the health ministry in its communiqué had also clearly indicated that pharma companies engaged in the manufacture of any of these 46 drugs was mandated to label them with an‘Rx’ indication on the strip.  The main reason for the government to introduce this Rule 65 (11-A) was because of the increasingly indiscriminate and irrational use of antibiotics, anti-TB drugs and habit forming drugs.

The reality is that there was no control on the over the counter sales of these drugs which were all prescription based and to be prescribed by the qualified doctors. The non-adherence to this has led to large incidences of drug resistance among the patients in the country, Bhandary told Pharmabiz.

“In the larger interest of the health of the population, indiscriminate sales of antibiotics, anti-TB drugs and the psychotropic drugs needed to be stopped. Further, there should also be strict self compliance in the sale of the 46 drugs listed under Rule 65 (11-A) to adhere to the provisions of Drugs and Cosmetic Rules 1945” he said.

Hospitals are facing problems as none of the antibiotics works and are faced with the escalating numbers of drug resistance leading to rising number of fatal cases. All this has resulted only because of the lack of control on sales of these 46 drugs which have led to mayhem,  he said, adding that the government was forced to impose the restriction on the sales of these drugs making the pharmacy outlets accountable by putting in systems of maintaining details of the number of prescriptions which required such drugs. Therefore the only choice before the drugs control department is to take action against the violators of Rule 65 (11-A), Bhandary stated.