Abhijit Das’s phone-cum-photocopy shop in Jadavpur looks like any other in Calcutta. It is only when he takes out a needle to take a blood sample from a waiting person that one realises that it is also a diagnostic collection centre. Yet the matchbox-sized shop is not just frankly unhygienic — it also has no facility for the refrigeration and storage of blood samples.

But Das is unfazed. “I forward the samples the same day to a diagnostic lab. So where is the question of contamination,” asks Das, who has been in the business for four years.

Das’s diagnostic sample collection centre is hardly an aberration. Thousands of such outlets, including doctor’s clinics, pathological laboratories, hospitals and nursing homes, are in operation where the barest of hygiene standards are not maintained. What’s more, the government has not even been able to maintain records of the existence of many of these clinical establishments.

But all that is set to change with the central government’s decision to table the Clinical Establishments (Registration and Regulation) Bill, 2010, during the Budget session of Parliament. “The law will provide a legislative framework for the registration and regulation of clinical establishments in the country and also improve the quality of health services,” said Union information and broadcasting minister Ambika Soni.

The new law has a provision for the setting up of a national council for standards (NCS), which will lay down the minimum standards to be followed in the health sector. Besides allopathy, NCS will also set standards for other ‘recognised systems of medicine’ like ayurveda, homeopathy and unani. The council will also rate clinical establishments according to the services they provide.

“One advantage of this legislation is that the government will now have a record of these establishments. Later it will look into their operating standards,” says Giridhar Gyani, director general, Quality Council of India, a government body that sets quality benchmarks for organisations.

A study commissioned by the Planning Commission for the Eleventh Five-Year Plan (2007-2012) revealed that the private sector accounts for around 50 per cent of in-patient care and 60-70 per cent of out-patient care in the country. “The private sector healthcare delivery system in India has remained largely fragmented and uncontrolled, and there is a clear evidence of serious deficiencies in many practices. The problems range from inadequate and inappropriate treatments, excessive use of higher technologies and wasting of scarce resources, to serious problems of medical malpractice and negligence,” the study noted.

Experts feel that the new law will address these deficiencies in private healthcare. “This law was long overdue. It will help to bring some basic standards in the healthcare sector,” says Dr Ketan Parikh, former president of the Association of Medical Consultants, Mumbai.

Practitioners of alternate medicine are also happy to be covered by the Bill. “If we are treated on a par with allopathy, the general public will have greater confidence in our system of medicine,” says Swapan Kumar Bhunia, ayurvedic doctor and member of the Central Council of Indian Medicine.

But those opposed to the law say that the government is being too ambitious here. “The NCS plans to set minimum educational standards for personnel in clinics and other places. But where are the trained personnel,” asks M. Abbas, former national president of the Indian Medical Association (IMA). Besides, uniform standards will be difficult to implement in clinics in rural and semi-urban areas, says Abbas.

But according to experts, once the new law comes in, diagnostic centres and pathological laboratories will be under pressure to deliver accurate reports. “Currently, labs often give varied reports on a single sample. This happens because there is an absence of trained personnel and the lack of proper equipment,” says Gyani.

This is not the first time that the government has tried to introduce a law to ensure quality standards in clinical establishments. A similar Bill was presented before Parliament in 2007. It was reviewed by the parliamentary standing committee as well, but the Bill lapsed after the dissolution of the last Lok Sabha.

One of the biggest problems regarding reforms in the health sector is that it is a state subject. For instance, if passed, this legislation will come into effect only in Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim and all the Union Territories, because these states had asked the Centre to implement such a law. Some states like West Bengal have their own laws on clinical establishments.

In fact, West Bengal has also come up with a new Clinical Establishments Bill. Unlike the central law, which focuses more on setting up a “national registry” for clinical establishments, followed by the formulation of standards, the West Bengal Bill’s main focus is on setting up a tribunal to look into complaints against erring clinical establishments. This tribunal will have the same powers as a civil court under the Code of Civil Procedure, and its rulings can only be challenged in a high court.

But like the central law, the West Bengal legislation too makes it mandatory for every clinical establishment to admit victims of accidents and those in need of urgent care, failing which a medical establishement’s licence could be revoked.

“Both the proposed laws have their own problems. The governments have set lofty goals even though they know that many of them cannot be met,” says Abbas who also deposed before the parliamentary standing committee that looked into the Bill in 2008.

One of the main complaints against both the central and state government laws is that government establishments will not be subjected to the same standards as the private ones. The parliamentary committee had suggested bringing state-run institutions under the purview of this law. But this suggestion has not been accepted, says a Union heath ministry official. “The government is expected to follow the rules it sets, so there is no need for explicitly mentioning it,” the official says.

But some experts are worried about the disconnect between the central and the state laws for clinical establishments. Hence many feel that there should be a common law that applies to the whole country. Even the parliamentary standing committee had asked the central government to try and persuade all the states to adopt the central law. “We certainly hope that we will be able to persuade them to adopt the central law. This will be very important for maintaining uniform health standards in the country,” says an official of the Union ministry of health and family welfare.

But according to Abbas, state governments are likely to “wilt” under the pressure of state associations and not adopt the central law. “Ideally, self regulation with strong government oversight is the best way forward. We don’t want the state and central governments to squabble and muddy the waters,” says Dr R.D. Dubey, vice-president, IMA, Calcutta.