The drugs control department of Tamil Nadu,for the first time, has started strict enforcement of Rule 65 (2) of the Drugs & Cosmetics Act & Rules to ensure sales of prescription drugs are done under the supervision of a registered pharmacist only in every retail store.
With this Tamil Nadu becomes the first state in the country to have strict scrutiny of sales of drugs on prescriptions by registered medical practitioners. The DCA administration head office in Chennai directly monitors the inspections in this regard to find any violation of the provision.
The department has initiated 158 prosecution cases against retail pharmacies for the violation of Rule 65 (2) in a period of nine months starting from April 2014 to January 2015. All the drug inspectors have been ordered to check the sales book and the prescription lists at the stores, and advised them to report to the concerned ADC offices if any such violation is found. The medical stores will not be allowed to sell prescription drugs without a pharmacist and information in this regard has been passed on to all retail outlets.
Section 65 (2) of the D&C act and rules says that “supply of any drug on the prescription of a registered medical practitioner shall be effected only by or under the personal supervision of a registered pharmacist”. Sharing information, some industry sources said there was no specific inspection on such provision by regulators till two years ago, and now the department wants strict enforcement of law, control and transparency in the supply of medicines everywhere in the state. Welcoming the decision of the department, the traders said the departmental action will create more confidence among the consumers of medicines on the integrity of the drug sellers.
Various pharmacists associations have earlier raised demands in this regard and approached the DCA to ensure the presence of registered pharmacists in all the medical stores. There was allegation from several corners that many of the community pharmacies were operating without the regular presence of qualified pharmacists, and one pharmacist’s licence was utilised by various stores without employing one person from pharmacy background. The drugs control department has taken this issue seriously and decided to enforce the act strictly in order to cleanse the drug market in the state. Now, no drug on a prescription by a doctor will be sold through any pharmacy without the scrutiny of the pharmacist.
A total of 358 prosecution cases have been filed in the court during this period against manufacturers, wholesalers and retailers of allopathic, ayurvedic and cosmetics products for violation of various provisions in the drugs and cosmetics act and rules, and of DMROA, said M Abdul Khadar, the director in-charge of the DCA.
A pharmacist association leader from Tanjore said the decision of the Tamil Nadu drugs control department would increase opportunities for employment for qualified pharmacists in the state and it would control the sale of spurious, sub-standard and date expired drugs.