With the Union cabinet deciding to table the Clinical Establishments (Registration & Regulation) Bill, 2007, in the monsoon session of Parliament, rules for clinical establishments like nursing homes, diagnostic centres, pathology labs and doctors’ clinics across the country are likely to be standardised.

There is a hitch, though. Since health is a state subject, the Bill if passed will only serve as a model for the states to adopt. But the good news is that many states have already expressed their willingness to implement the law in its letter and spirit once it is passed by Parliament.

“At a time when the government is focussing on transparency in all its services in the form of the Right to Information Act and other such measures, there is no reason why private health establishments should not be brought to book. NGOs in the health sector have for long been pleading for such a measure. I am glad the government has finally taken it up,” says Ashok Dyalchand, director, Institute for Health Management, a non-governmental organisation involved in health-related issues in Pachod, Aurangabad.

According to a working group, Clinical Establishments (Professional Services Regulation) and Accreditation of Healthcare Infrastructure for the Eleventh Five-Year Plan (2007-2012), set up by the Planning Commission, the private sector accounts for around 50 per cent of inpatient care and 60-70 per cent of outpatient care in the country.

“The private sector healthcare delivery system in India has remained largely fragmented and uncontrolled. There is clear evidence of care deficiencies in many practices. The problems range from inadequate and inappropriate treatment, excessive use of higher technologies to wasting scarce resources and serious problems of medical malpractice and negligence,” the group noted.

Some of the key proposals of the Bill are inclusion of hitherto uncovered establishments such as alternative medicine systems like homeopathy, unani, siddha and ayurveda; the setting up of a National Council of Standards which will prescribe minimum standards for healthcare services and compulsory registration of all clinical establishments in the country.

Chandrima Chatterjee, senior research officer at the Centre for Enquiry into Health and Allied Themes — a Mumbai-based organisation which handles research and advocacy on the regulation of the private sector — is upbeat about the Bill. “While public services have certain norms and standards, private services operate in an unregulated fashion,” she points out. “So the move towards regulation and licensing is a positive step.”

States such as West Bengal, Maharashtra, Himachal Pradesh and Delhi have their own laws on clinical establishments. But they have not been very effective. “Despite the basic legislation, the enforcement of regulatory controls is often lacking. States have limited capacity and resources to effectively implement the existing regulations,” the Planning Commission’s working group noted.

That is why even members of the Indian Medical Association (IMA) are optimistic about the Bill. “This would provide the right direction to state governments. We were in need of a law, formed in consultation with all the stakeholders,” says Dr R.D. Dubey, vice-president, IMA (Calcutta). He feels once the central law is passed, West Bengal may have to replace the “draconian” West Bengal Clinical Establishment Rules, 2001. “If one were to go by the rules in that Act, around 80 per cent of all the medical establishments would have to shut shop. The state Act does not take ground realities into account,” he notes.

Once the law is passed, diagnostic centres and pathological laboratories will feel the heat. “Laboratory reports of a single sample often vary from lab to lab. That is unacceptable. The more so because doctors have to rely on laboratory reports and prescribe medicines according to those reports,” says an indignant Dyalchand.

Giridhar Gyani, director general of the accreditation council, Quality Council of India, agrees. “Some of the diagnostic labs conduct tests with the same machines for years without running a regular check on them. So the test results vary. For this to be rectified, it is imperative to set up a regulatory authority which issues clear-cut guidelines,” he says.

With the implementation of the law, even a doctor’s prescription is likely to undergo a change. “In India, doctors treat a medical prescription as some kind of secret. This Act is likely to mention that a doctor should clearly state why he or she prescribes a certain medicine. This will bring in transparency,” says Dyalchand.

But not everybody is happy with the Bill in its present form. “The government should simplify the rules ,” says Rakesh Sharma, owner of a pathological laboratory in Delhi. “What’s the need for regulations if it is stated that only qualified pathologists can run a laboratory,” he asks. Sharma, however, is not against the laying down of minimum qualifications for lab technicians and other specifications.

It is clear, however, that once all the states adopt the central law, it will make things difficult for nursing homes, laboratories and diagnostic centres that operate in the back alleys and by-lanes of cities and towns. “It will be good for people in general, as unscrupulous elements who are in the profession will be forced out. But for this to happen, the law, like any other law, has to be implemented,” says Dubey.

Dr Ketan Parikh, former president of the Association of Medical Consultants, Mumbai, who is in favour of self-regulation by the medical community, highlights another point. “The cost of treatment should not become exceptionally high after the implementation of the standards. Also, to ensure these standards, infrastructural facilities have to be created — for instance, we must have qualified nurses, a steady flow of electricity and specialised equipment.”

Implementing the Act in rural areas may prove to be difficult. “In some rural areas, healthcare is provided at a low cost with the help of trained yet unqualified nurses and paramedics. There are fears that such an Act would increase the cost of basic healthcare without making a significant difference in the quality of care. It would enable the government to withdraw from its healthcare responsibility and allow insurance companies to have a field day,” underlines Chatterjee.

What is needed then is a law which is simple and implementable. “Only that can pacify all those concerned with healthcare issues,” sums up Dyalchand.