The Indian Pharmaceutical Association (IPA) has suggested a slew of initiatives to be incorporated in the pharma policy proposed by Department of Pharmaceuticals (DoP) including creation of Ministry of Pharmaceuticals for single window regulatory clearances and better synchronization of operations.

The other suggestions include accord infrastructure status to the pharmaceutical & biotech industries for speedy growth and recognising pharmacist as only professional for drug regulatory, drug policy-making, drug handling and pharmacy education-related teams and building quality human resources.

The suggestions were sought by the DoP for drafting proposed pharmaceutical policy. The DoP secretary had on April 21, 2017 called a meeting of stakeholders including professional pharmaceutical associations and industry bodies seeking their suggestions for the forthcoming pharmaceutical policy.

Once the Ministry of Pharmaceuticals is created, it will effectively bring in all regulatory and related activities of DCGI, India Pharmacopeia Commission, Pharmacy Council of India, NPPA, NIPERs and Pharmexcil, public sector drug companies under one roof. All requisite permissions for setting up manufacturing/clinical research/contract research/R&D/sales/distributor/retail units would then be obtained from a single window, under the ministry, as against the multiple approvals currently required from different ministries and government departments for setting up a pharma business venture. The reduced approval timelines with a single-window regulatory clearance would contribute greatly to the ease of doing business and would bolster growth of the pharma industry, said Dr Alka Mukne, Editor of Pharma Times, published by IPA while outlining the suggestions.

The government can also look at introducing examination of Indian Pharmaceutical Services in the line with civil service examinations which could be taken up by pharmacists keen on government service in the Ministry of Pharmaceuticals, she opined.

The pharmaceutical & biotech industries should be accorded infrastructure status so that better finance options are made available and capital inflow into the industry is facilitated. Special designated zones/parks for encouraging production of APls, critical intermediates and starting raw materials as well as finished pharmaceutical and biotech products should be created by the government to provide a fillip to this sector, she added.

Pharmacist is an indispensable member of the health care team. The role of the pharmacist in prescription audits in the retail as well as hospital setups needs to be developed for achieving better and improved health care delivery.

Pharmacists should be considered for all positions at levels in the Ministry of Pharmaceuticals, drug regulatory framework, drug policy making bodies, drug industry, pharmacy education-related teams, drug handling teams including drug distributors, wholesalers and stockists. Implementation of these measures would ensure building and maintenance of quality in all aspects pertaining to drugs and medicines.

Pharmacy education in the country can be strengthened by increasing the government spend in terms of creating more NIPERs and providing increased support to state-funded and private educational institutes conducting quality research programmes. The pharma industry support to the educational institutes is vital and industry should be encouraged to outsource activities such as mandatory BA/BE studies, preclinical research, drug development and scale-up projects (projects that do not entail serious confidentiality issues) to pharmacy academic institutes of repute, she stated.

Pharmacy/pharmaceutical sciences should be included as one of the subjects in the civil services examination so that pharma professionals who understand the needs and requirements of the pharmacy profession have a better opportunity to get involved in the civil services, thereby contributing in a more effective way towards pharma policy-making and implementation, Dr Mukne concluded.