Quality Council of India (QCI) has urged all the healthcare providers in the country to ensure that they follow all quality standard guidelines recommended by the government to avoid any complications that may compromise patients safety in the hospitals. This demand comes in the wake of the devastating fire at Amri Hospital that claimed lives of 190 people due negligence on the part of the hospital.

With a view to ensure that all the hospitals in the country are sensitised about the importance of following all the quality and safety regulations, QCI had recently organised its first national quality conclave for the healthcare sector in Bangalore. The conclave focused on enhancing the quality in healthcare system of the country and deliberate on the issues that hinder in deliverance of quality service.

According to Rajendra Pratap Gupta, member, Healthcare-Quality Council of India, “It is not possible to provide accreditation to all the hospitals at once since its takes a lot of time as well as man power to do that. However it does not mean that the hospitals that are not under National Accreditation Board for Hospitals and Healthcare Providers (NABH) should fall behind. We want the healthcare providers to understand that accreditation is important but at the same time it is not beyond quality. We want to ensure and change the way things are perceived today by stressing on keeping up with our motto to ensure quality healthcare in the country.”

He informed that as on date NABH, which is a constituent board of QCI has accredited nearly 140 hospitals and another 500 plus hospitals are preparing for accreditation in the country. The accreditation programme by NABH covers all the facets of patient safety including surgical safety, medication management, hospital infection and patient communication. The primary goal of accreditation is to ensure that the hospitals not only perform evidence based practices but also give importance to access, affordability, efficiency, quality and effectiveness of healthcare. However, he stressed that though approval is essential steps must be taken to look beyond accreditation to address and deal with quality issues in the present healthcare system.

The conclave that was co-organised by Bronze Certification of Lean by Simpler UK at M S Ramaiah Medical College & Hospital in Bangalore provided critical inputs pertaining to various facets of quality in healthcare.

“Quality in healthcare is of paramount importance as it directly impacts human lives and unlike quality in other sectors, quality in healthcare relates to a hospital monitoring and measuring clinical outcome on a continuous basis. Through this conclave, which will be a quarterly event, we want to bring in all the healthcare providers under the same roof so that we can exchange new ideas and deliberate on issues and challenges that will have a far reaching effect on the way healthcare system is dealt in the country,” Gupta said.

He further informed that looking at the quality issues in the East zone, QCI has decided to organise the second conclave in Kolkata in March next year followed by west and north zones respectively.

After more than three years of inter-ministerial and government-public debates and discussions, the Union health ministry has at last given the final shape to the much awaited Assisted Reproductive Technology Bill (ART Bill). The Bill will soon be sent to the Union cabinet for its nod to be introduced in Parliament.

According to sources in the Union health ministry, the Bill has received nod from all the concerned ministries including the union law ministry where the Bill was pending for a long time for its mandatory nod. A cabinet note on the Bill will be prepared soon and will be sent to the cabinet for its approval for introducing the same in Parliament, a senior official involved in preparing the Bill said.

The Bill was waiting for quite some time for the nod from the department of law, after the Indian Council of Medical Research (ICMR), which was given the responsibility of drafting the bill, had completed all the scientific part of the Bill. The ART Bill is being introduced in the country to regulate thousands of infertility clinics that have mushroomed in the country over the years.

The introduction of the bill is important as the last nearly 20 years have seen an exponential growth of infertility clinics that use techniques requiring handling of spermatozoa or the oocyte outside the body, or the use of a surrogate mother. As of today, anyone can open infertility or ART clinic. No permission is required to do so. There has been, consequently a mushrooming of such clinics throughout the country.

In view of this scenario, it has become important to regulate the functioning of such clinics to ensure that the services provided are ethical and that the medical, social and legal rights of all those concerned are protected.

The Bill, once it gets the Parliament nod, will provide a national framework for the accreditation, regulation and supervision of infertility clinics, for prevention of misuse of assisted reproductive technology, for safe and ethical practice of assisted reproductive technology services and for matters connected therewith or incidental thereto. It provides for the constitution of a 21-member National Advisory Board, under the chairmanship of secretary, department of health research, and also state boards, to exercise the jurisdiction and powers and discharge the functions and duties conferred or imposed on the Board by or under this Act.

Under the new Act, all infertility clinics, ART banks and research organizations using human embryos have to register themselves with the registration authority.

The Bill details about the procedures for accreditation and supervision of infertility clinics (and related organizations such as semen banks) handling spermatozoa or oocytes outside of the body, or dealing with gamete donors and surrogacy, ensuring that the legitimate rights of all concerned are protected, with maximum benefit to the infertile couples/individuals within a recognized framework of ethics and good medical practice.

The clinical trial industry in the country is annoyed over the continued delay in giving approvals for the clinical trials, including the bioavailability and bioequivalance (BA/BE) studies, by the office of the Drug Controller General of India (DCGI).

Industry sources said that ever since the controversy surrounding the Hyderabad-based CRO Axis Clinicals hit the headlines, the DCGI office has virtually stopped giving clearance to clinical trials including the BA/BE studies and ordered auditing of all the Clinical Research Organisations (CROs) in the country to ensure that these studies are performed strictly in accordance with the applicable regulatory provisions and prescribed guidelines in the country.

Admitting that the clinical studies should be done strictly in accordance with the prescribed guidelines in the country, industry sources however said that the inordinate delay in getting approval from the DCGI office is adversely affecting the clinical trial sector as a whole in the country as the business is gradually shifting to other countries where decision making is fast and prompt.

They said that at a time when there is intense competition in the field, the non-clearance of these studies by the Indian regulators will adversely affect the Indian CROs. Due to its several factors including cheap labour and skilled workforce, India is becoming a hotspot for clinical research activities in the world. But this kind of attitude by the Indian regulators will act against the overall interest of the CROs in the country, they said.

The regulators started tightening the regulations on the clinical trial sector in the country after the controversy in June this year surrounding the Hyderabad-based CRO, Axis Clinicals, in which the company is alleged to have conducted clinical trials of a breast cancer drug on nearly 30 illiterate agriculture labourers after luring them with Rs.10,000 each. The incident created such a hue and cry in the country over the illegal activities of the CROs that the DCGI ordered auditing of all the CROs in the country.

His decision was prompted by the findings in the investigations on Axis Clinicals which revealed that there were various irregularities in conduct of BA/BE studies with respect to subject recruitment process, informed consent process, independence of the Ethics Committee and its review and decision making process.