Around 20,000 clinical establishments in Tamil Nadu failed to register under the Tamil Nadu Clinical Establishments Act, 2018 within the May 31 deadline because of high registration fee, disposal of biomedical waste norms and floor space for laboratories.
The Act, framed in March 2018, mandates all clinical establishments — public and private — to register with the state government. It also permits the DMS to shut down or take action against clinical establishments that have not applied for registration starting July. Thus a number of these establishments may shut down in the state due to non-compliance with the law.
The state has around 50,000 clinical establishments but the Directorate of Medical Services (DMS) has received only 29,000 applications till date. “Once the process of receiving applications is complete, we will gather information about non-registered clinical establishments,” Kamala Kanan, Superintendent of DMS, told The Federal.
The list of non-registered clinical establishments will then be sent to the enforcement department, Kanan said, who will take the required action against them. The rules ensure standards in every establishment and list facilities that an establishment should have such as sufficient space, ventilation, fan and water supply.
“We do not have any problem in registering with the state government but issues arise when it comes to certain norms laid down by the government. Norms involving the management of biomedical waste, surface areas of laboratories and periodic registration fees are unnecessary,” Dr Shanthi AR, Secretary of Doctor’s Association for Social Equality told The Federal.
Floor space for laboratories
The Act lays down specific norms for each clinical establishment. For instance, in the case of laboratories they specify the floor space of up to 500 sq ft in rural areas and 700-1,200 sq ft in urban areas. Laboratories that do not meet these criteria face difficulty in registering.
“More than 20,000 laboratories and 50,000 workers are affected due to the Clinical Establishments Act,” P Kalidass, president of Tamil Nadu Medical Laboratories Association, told The Federal.
Earlier, Tamil Nadu laboratory associations and unani practitioners had moved to the court, citing the specifications in the act as “too stringent”. They had pointed out that single room labs in rural areas in the state may not fulfill the requirement.
“Registering with the state government is a good move but there are so many rules that are not needed,” she said.
Disposal of biomedical waste
Another reason why small clinical establishments are hesitant for registering with the state government is the biomedical waste norms. The government has made it mandatory for such clinics to have provisions for disposal of biomedical waste when they generate none. Smaller clinics are now forced to sign a memorandum of understanding (MoU) with a private agency listed by the government to come and collect even the little biomedical waste that it generates, Dr Shanti said.
Since only limited private agencies are listed by the government, laboratories as well as clinics are forced to pay a higher sum (₹1,000 per month) to the agency for collecting biomedical waste. “The government should take the responsibility of disposing biomedical waste. In Mumbai, the municipal corporation collects biomedical wastes at ₹500 per month. The Tamil Nadu government can do so too,” Kalidass said.
High registration fee
Every clinical establishment is required to pay a registration fee of ₹5,000 to get the certificate to practice for five years. Since the fee remains the same for small clinics and big hospitals such as Apollo, the former feel that the registration fee is high.
“In Andhra Pradesh, clinical establishments have to pay just ₹500 per year for registration,” Kalidass said, adding that the registration fee should be brought down. The Tamil Nadu Medical Laboratories Association has filed a petition to the High Court proposing them to bring down the registration fee and relax the floor space norms for laboratories. The hearing for the case is on July 16.