Indian Pharmacopoeia Commission (IPC) needs autonomy status for a better administration of this body and to take effective steps to ensure quality standards in the pharma industry. Frequent bureaucratic interventions bring hassles in its way of its effective functioning, according to the experts.
The view came out during an interactive session on Indian Pharmacopoeia 2007 on the occasion of the launch of its new edition in Delhi. Attended by different stakeholders and other eminent pharma scientists, the session was held by Indian Pharmacy Graduates' Association (IPGA) and the IPC here recently.
Dr P R Pabrai, former vice-president of scientific committee to IPC, said that the Commission should be given autonomy in terms of making its own regulations and financial freedom. It would fulfil its financial need in setting up facility for the better scientific studies, he said.
AIDCOC president Ravi Kant also expressed his concern, saying that the chairperson of the commission should be a scientist and not a bureaucrat. He said that only a scientific person can evaluate the need of the scientific body and can better implement the demands comes from it.
It may be noted that the IPC retains three bodies -- the general body, the governing body and the scientific body. Scientific body depends for all its proposals on governing body which discusses the matter with the general body and chairperson. Later, proposal goes to the ministry of health and family welfare for approval.
Pabrai said that once the proposal reaches in ministry it takes a lot of time to be passed and because of this, taking a decision gets delayed. "Two years ago scientific body gave a proposal to the governing body for the appointment of 28 scientists which was later reduced to eight and sent to the ministry for the approval but not been sanctioned till date, " added Pabrai.
IPGA president Atul K Nasa chaired the session and Dr G N Singh, member secretary-cum-scientific director of Indian Pharmaceutical Commission, conducted it. New DCGI Surinder Singh and, former DCGI M. Venkateswarlu were among those who attended the launching function of IPC.
Dr Venkateswarlu, while commending the IPC team, said "India has proved that it retains the capability of making a quality standard for pharma companies. It's a unique example when industry, academia and regulatory people came together to perform a tremendous work". He also advocated for including the information regarding drugs kinetics called 'pharmacokinetics' in pharmacopoeia.
"We have to set up the standards on international level and should be ready to be compared and be first with any pharmacopoeia of any country", Dr Surinder Singh said, adding that quality was non-negotiable thing and should be maintained at any cost.
Dr RK Khare, professor of Jamia Hamdad, said that impurity standards of drugs should also be included in pharmacopoeia while some participants called for elimination of categories and dosage forms of drugs. Prem K Gupta former DCGI suggested that medical devices which had been notified as drugs should also be tested and IPC should lay down their standards, especially for those 'stents'.