Although the Pharmacy Act came into existence in 1948 in the country, most of the state pharmacy councils have not appointed pharmacy inspectors for the effective implementation of the Act for all these years.
The only two states which have pharmacy inspectors in the country are Kerala and Maharashtra. Kerala has 14 pharmacy inspectors for all its districts whereas Maharashtra has just two for the entire state.
This is despite the fact that country had witnessed substantial growth in the number of pharmacy stores in the private sector, in government hospitals and in public health centres over the years. Presence of qualified pharmacists in retail pharmacies and healthcare institutions has been enforced stringently by the state drug regulators but on the contrary state pharmacy councils have failed to appoint pharmacy inspectors due to operational, administrative and financial issues. And as experts pinpoint that appointment of pharmacy inspectors becomes more crucial with diverse drugs entering the Indian healthcare including new chemical entities and biological substances.
Kerala and Maharashtra are the only states which have taken a step forward in implementing section 26 A of the Pharmacy Act, 1948 by appointing pharmacy inspectors. Kerala has been able to do 10, 000 inspections so far and has identified six cases of violation of the Pharmacy Act since its implementation. The state government has also allocated Rs. 30 lakhs for the council's activities for the financial year 2013-14.
Pharmacy Act asks for more stringent implementation and enforcement with the help of pharmacy inspectors as Dr B Suresh, chairman, Pharmacy Council of India (PCI) puts it, "There are one million pharmacists and around seven lakh chemists across the country. The task of keeping a tab on them is a challenging one but there is a need to empower pharmacy inspectors as facilitators in the process of pharmacy practice as the requirement is huge."
In the case of Maharashtra, there are two pharmacy inspectors under its jurisdiction. One inspector is posted in Mumbai and another one is posted at Nashik Division currently. Both the pharmacy inspectors are supposed to conduct inspections in every district of Maharashtra on a weekly basis followed by a monthly report as per the administrative orders or schedule mandated.
Appointment of pharmacy inspectors in Northern States like Delhi and Uttarakhand also reflects a grim picture with Delhi having around 10, 000 retail pharmacies and over 400 healthcare institutions including corporate and government hospitals with no pharmacy inspectors. There is a requirement of one pharmacy inspector in each of the nine districts of Delhi as of today. SL Nasa, registrar, Delhi Pharmacy Council (DPC) said, "We have reminded the state government five months back about the proposal for appointment of pharmacy inspectors which has been festering for the past five years." He further informed that the proposal is still under consideration.
A meeting was convened in the month of March this year of all respective state council registrars and presidents under the president ship of Dr B Suresh for appointment of pharmacy inspectors as provisioned under the Act. Dr Suresh informed, "Till date we have not got a satisfactory response on the same. We are in the process of writing to the state health secretaries through the Ministry of Health and Family Welfare, Government of India for its proper implementation."
"Taking big states like Maharashtra and Rajasthan into consideration, respective state councils should depute pharmacy inspectors geographically in a way so that they can enforce the law in an effective way," he added. According to Dinesh Sachdeva, registrar, Rajasthan Pharmacy Council, "We have submitted a proposal for the appointment of six pharmacy inspectors to the state government a few months back and are awaiting the response."
Citing funds constraint not being as one of the reasons behind not appointing pharmacy inspectors, Dr Suresh clarified that funds is not a problem as a good amount of registration fee is collected by respective state councils across the country from around 60,000 pharmacists every year. Besides that, the post of pharmacy inspectors is not a full time salaried job as is the case with drug inspectors with the state drug administration. Pharmacy inspectors can be appointed on honorarium basis which respective state councils can easily arrange for without help from the state governments.
Experts advocate the Pharmacy Act as a whole need to be reviewed taking into consideration the present circumstances more so as it came into being in 1948. According to Pradip Trivedi, president, Gujarat State Pharmacy Council (GSPC), "The need for pharmacy inspectors has not been realized in Gujarat going by the argument that it will create confusion and conflict of interest between drug inspectors and pharmacy inspectors if it materializes." Gujarat State FDA which boasts of 150 drug inspectors earlier had around 45 inspectors to inspect over 28,000 retail pharmacies.
Uttarakhand State Pharmacy Council (USPC) shares the same version which has 1500 government healthcare institutions which are being inspected by around 12 drug inspectors. "There is no need for pharmacy inspectors as the inspections are successfully done by drug inspectors under the Drugs and Cosmetics Act, 1940," informed M L Joshi, registrar, USPC.