With a view to safeguard the interest of the patients in the state, the Directorate of Food & Drugs Administration, Goa warned all the stakeholders with stringent action on flouting any rules in the new Schedule H1.
Schedule H1 of the Drugs & Cosmetics Rules 1945, made effective from March 1, 2014, was introduced to keep in check and control indiscriminate, inconsistent and irrational use of antibiotics, anti-TB drugs, believed to be the leading cause of large incidences of drug resistance among the patients in the country. The new Schedule covers a list of 46 drugs consisting of antibiotics, anti-TB drugs and also some habit forming psychotropic drugs. The Schedule requires every chemist to ensure that strict records are being maintained on the supply of such drugs.
It also makes it mandatory for the chemist and pharmacists to dispense the medicine only on the prescription of registered medical practitioners, records of which should be maintained for a period of three years from the date of its supply and be made available for verification at any inspection conducted by the regulatory officials. Interestingly, to ensure total and strict adherence to all the provisions of the new Schedule H1, the drug regulator from Goa recently had a meeting with the chemists, pharmacist and medical stores in the state. The meeting focused on sensitising the stakeholders on the requirements, procedures and the various records maintenance necessary in the strict implementation of the new Schedule H1.
Salim A Veljee director, Food & Drugs Administration (FDA) cautioned that strict action will be taken against those who fails to comply with the provisions of the said law. “We want the stakeholders to understand that drugs falling under the Schedule H1 should be sold only on prescriptions of registered medical practitioner and in the presence and personal supervision of the registered pharmacist. They should also make sure that they maintain all the required records to substantiate their sales and purchases of such drugs to the regulators. Any instance of non-compliance would be dealt by the FDA with severe and harsh punishment which includes suspension and cancellation of their drugs licenses,” warned Veljee who is also the president, Indian Pharmaceutical Association (IPA).
He also cautioned that the pharmacists need to exercise all restraints against indiscriminate sale of the psychotropic and other habit forming drugs including sale of sildenafile citrate category of drugs to patients including foreigners at the coastal belts of the State without proper verification and authentic prescription. In the meeting which was jointly organised with the Indian Pharmaceutical Association (IPA), Goa state branch, Veljee and his team also addressed some of the doubts and challenges relating to the implementation of Schedule H-1 drugs and Rule 65, which restricts the chemists and druggiest from dispensing substitute brand to the patients.