CDA formation, DPCO, dual control over pharmacy education to dominate IPC discussions
The Indian Pharmaceutical Congress (IPC) will make a strong pitch for leaving the control of pharmacy education exclusively to the Pharmacy Council of India (PCI), instead of the present system of dual control maintained also by the All India Council for Technical Education (AICTE).
Over the years, the policies of AICTE are resulting in mushrooming growth of pharmacy institutions, thus adversely impacting the quality of pharmacy education leading to poor admissions throughout the country, according to a discussion note that will be taken up at the mega meet involving different stakeholders.
“It is hence imperative at this stage that the profession of pharmacy has a single regulatory control and all powers should be vested with PCI. It should have complete authority and accountability to improvise the educational standards at all levels. Effort need to be augmented to complete this process at the highest level including the parliament of India to make necessary amendments immediately,” it said.
The IPC is also expected to suggest some amendments to the Drugs and Cosmetic Act, 1940 and Rules 1945. One of the amendments being suggested is the rule 64. “The Qualification for the post of competent person in the Drugs & Cosmetics Act, 1940 & Rules 1945 for obtaining whole sale drug license by C&F Agents, wholesale distributors, stockiest, sub-stockiest etc. may be amended and qualification should be only a Registered Pharmacist in place of matriculation, intermediate, graduation or any other non - pharmacy qualification,” it said.
“It is proposed that the Qualification for the Post of Competent Technical Staff for manufacturing of drugs, may be amended and only a Graduate in Pharmacy should be allowed as the competent technical staff. All other qualifications viz. graduate in science, chemistry or in chemical engineering or chemical technology or medicines etc. should be deleted,” the note said.
The meet will also recommend to the Centre and the States to strictly follow the recommendations of the Mashelkar Committee report. “It is unfortunate that instead of implementing the recommendations of Dr Mashelkar Committee Report, the Central Government’s focus is on establishing Central Drug Authority, despite the fact that Dr Mashelkar Committee and the Parliamentary Committee under the chairmanship of Amar Singh did not favour such step. The Central Government’s proposal to centralize drug manufacturing licensing is also against the federal structure and well defined responsibilities of Central and State Governments. The Drugs and Cosmetic (Amendment) Bill needs a relook,” said the note.
The meeting of the stakeholders will also assess the impact of GATT & TRIPS on the prices of new drugs. The Govt. should take some measures so that new drugs are available to the public at reasonable prices particularly to the patients of cancer and AIDS, according to the paper.
“Being signatory to GATT and TRIPS, the need is felt to boost R&D activity. The government has brought 348 drugs under the purview of the Drugs Prices Control Order (DPCO) which may bring down the profitability of pharma companies. The Govt. should announce some sops to pharmaceutical industry in the coming budget so that adequate amount of money can be utilised on research,” it said.