Even as the Clinical Establishments (Registration & Regulation) Act (CEA) 2010 mandates that the state councils for CEA should have representatives from medical council, dental council, nursing council and pharmacy council, the Kerala government is moving ahead with the formation the new state council for CEA without any representatives from state pharmacy council in it.

As per the central Act 2010, every state has to constitute a state council for CEA under the chairmanship of health secretary for regulating the clinical establishments such as hospitals, nursing homes and laboratories. The Act contends that out of the four members proposed to the executive committee, one member should represent the respective state pharmacy council. But in Kerala, the government has not included any representative from the pharmacy council, sources from Kerala State Pharmacy council (KSPC) informed Pharmabiz.

Quoting a letter from the state health secretary in reply to KSPC’s request,  KSPC president B Rajan said the draft bill for the state council has already been prepared and it will become a subject of discussion in the next Assembly session. He said the health secretary’s letter to the pharmacy council says that the time fixed for inclusion of representatives has ended, hence it is not possible to include a KSPC representative into the newly constituting clinical establishments regulatory body. Following this, the KSPC has approached the government for further consideration.

Alleging that it was a deliberate attempt from the health department in violation of the law, Rajan said that there are representatives from the state medical council, nursing council and dental council in the CEA state council.  He has given a complaint to the state health minister, to the ruling party’s president and to all the MLAs in the state. He further said the council will approach the union government and the central pharmacy council against this infringement of law.

As per chapter 3, section 8 (2) of the central Act, the state council for clinical establishments should consist of, in addition to health secretary, DHS and directors of various branches of ISM, one representative each from state MCI, state DCI, state NCI and state PCI. The health secretary is the chairman of the council and it is his duty to include all the representatives in the council.

According to government sources, once the state council is formed, all the clinical establishments including hospitals, clinics and the laboratories will have to register with the council. However, those laboratories which are operating under registered hospitals do not need to register separately. But the violators of the law will have to face severe penal actions. The Act insists a penal amount ranging from Rs. 10,000 to Rs. 1 lakh according to the class of the establishments. The Act will also crack the whip on the workers who knowingly do services in the unregistered establishments.

Meanwhile, some central government institutions like HAL Lifecare Limited and Rajiv Gandhi Centre for Biotechnology have expressed willingness to start laboratories in the district hospitals and general hospitals to provide their services to the public on a minimum rate.