New Delhi: The government may modify its proposal to centralize drug licensing as part of a draft law as it attempts to revive the legislation and introduce it in Parliament during the monsoon session.
This key part of the Central Drug Authority (CDA) Bill, 2007, had emerged as a stumbling block, with lawmakers and sections of industry raising their objections to the plan.
Under the Bill’s provisions, licensing powers currently with the states would be transferred to the authority, including the issue of drug manufacturing licences of existing and new medicines.
“We will now relook at the central licensing proposal of the Bill, whether we actually require it or not, because this is a contentious issue,” said Surinder Singh, drug controller general of India.
The CDA Bill is part of the government’s key reforms as it updates legislation to cover advances in science and technology, covering the use of sophisticated devices, treatment methods, and research norms.
Union health minister Ghulam Nabi Azad said last year that the cabinet had decided that wider consultations should be carried out with all concerned ministries and state governments.
The lack of progress is holding up other critical areas in which legislation is urgently needed. “There are issues such as the penal provisions for violators of human clinical trial norms and the regulation of medical devices that are part of the CDA Bill,” Singh said. “We need to speed these regulations up.”
The proposal for central licensing has been criticized by state drug authorities and industry bodies, which argue that the envisaged structure won’t be workable as the infrastructure isn’t yet in place.
“For every company to come all the way to the Centre for a simple licence is too tedious,” said T.S. Jaishankar, chairman of the Confederation of Indian Pharmaceutical Industry (SSI), the apex body of small-scale manufacturers of drugs and pharmaceuticals. “The Centre needs to look into all these issues.”
“We will come up with an alternative. For instance, we could have an overriding power for the drug controller general of India to cancel the licence in a state, which we cannot do at the moment,” Singh said.
Giving all the power to the Central authority and none to the state food and drug authorities wouldn’t be appropriate since many of them perform their functions well, said Daara B. Patel, secretary general of the Indian Drug Manufacturers’ Association.