Planning Commission has called for urgent steps to strengthen the regulatory systems in the health sector by the States, where most of the implementation rests, but urged the Centre to take the lead action to prompt the States.

“Regulations for food, drugs and the medical profession requires lead action by the Central Government not only because these subjects fall under the Concurrent List in the Constitution, but also because the lack of consistency and well enforced standards hugely impacts the common citizen and diminishes health outcomes,” the document for the current 12th Plan period says.

“There is also an urgent need to strengthen the regulatory systems in the States, where most of the implementation rests. This would entail the strengthening of and establishment of testing labs and capacity building of functionaries. Such proposals will be part-funded under the National Health Mission (NHM). Regulation can be made affordable and effective by encouraging self-regulation, and entrusting responsibility to Public Health officers,” it said.

The provisions for registration and regulation of clinical establishments would be implemented effectively; all clinical establishments would also be networked on the Health Information System, and mandated to share data on nationally required parameters. The Government would consider mandating evidence based and cost-effective clinical protocols of care, which all providers would be obliged to follow. It would endeavour to gradually move towards a regime where clinical decision-making would be routinely subjected to prescription audits to confirm compliance, the Plan panel said.

“The rights of patients to obtain rational treatment of good quality at reasonable cost would be protected. Professional councils and faculty in medical colleges shall be encouraged to undertake prescription audits to assess extent of compliance with Standard Treatment Guidelines for identifying violations of guidelines and taking appropriate action. There is a need to revise and strengthen the existing regulatory mechanism for medical practice to prevent wilful negligence and malpractice. Grievance redressal mechanisms would be put in place,” the document said.

“Since there are no legislations on registration of clinical establishments in many States, and the ones existing (as in States of Andhra Pradesh, Maharashtra, Delhi, Madhya Pradesh, Manipur, Nagaland, Odisha, Punjab and West Bengal) have major gaps, all States will be persuaded to adopt the Central Act under Clause (1) of Article 252 of the Constitution,” it said.

An appropriate regulatory mechanism would be considered to ensure compulsory rural service by medical graduates. Concurrently, a set of monetary and non-monetary incentives would be built up to encourage doctors and allied health cadres to serve in rural areas, the Planning Commission suggested.