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Gujarat To Bolster Healthcare Sector

Gujarat is now looking for upgradation of healthcare sector in the state to provide better social life. For the purpose, the state plans to introduce Public Health Act to streamline the health sector and address the entire gamut the health related issue.

There would be a system to enforce the quality of health service and provide quality life to people. which will essentially focus on monitoring all healthcare institutions in the State. Right from directives to healthcare institutions to treat medico-legal cases, to streamlining the growth of Clinical Research Organizations (CRO) to bringing non-communicable diseases under its purview, the act promises to reform the health sector.

Under the proposed Act, no healthcare provider or establishment shall delay treatment merely on the grounds of receiving police clearance or a police report. It also proposes to provide relief to the people by saying that the healthcare provider shall not refuse a person emergency medical treatment, until the person stabilizes, irrespective of his paying capacity, announced Gujarat Health Minister Shri Jay Narayan Vyas.

The proposed law says that a healthcare establishment shall not provide a health service for experimental or bio-medical or clinical research purpose, except according to guidelines laid down by the Indian Medical Council for Medical Research. The proposed law provides that every bio-medical and clinical research studies shall be carried out only after prior registration with designated authority.

Gujarat has 14 universities and more than half a dozen research institutes imparting post graduate and undergraduate courses in biotechnology and related allied sciences. About 20 institutes offer UG courses, 5 offer PG courses, 6 offer doctoral courses and 7 offer diploma courses. The state produces around 5000 manpower trained in biotechnology, which includes PhD.s, Post Graduates, PG Diploma, undergraduates and other diploma courses, in various biotechnology related disciplines.

(Ref: Chronicle Pharmabiz July 17, 2008)

CII To Organize Seminars On Regulation On Medical Devices

In the wake of DCGI’s warning of strict action against the medical devices  manufacturers, who run their business without licenses, the CII is making efforts to bring the regulators and the industry on a single platform to instill awareness on the issue of regulation on medical devices.

Even though the government has brought 10 more medical devices under government regulation through a notification dated way back on October 6, 2005, there has been little impact on the industry and the medical devices industry remained by and large an unregulated segment. The major reason for this situation is that the regulation looked optional and there was no motivation for the domestic industry to comply with the government order, sources said adding there was lack of clarity about the
regulation.

To bring clarity and also to help domestic medical devices industry to understand the regulation better, the CII in association with the CDSCO is planning to organize a series of awareness seminars on the issue in different cities of the country. The first such seminar is proposed to be held in Mumbai in the end of September or early October this year, which will be followed by seminars in other major cities to shed more light on the issue of regulation on manufacturers of medical devices.

As per data available with the union health ministry, only a handful of medical devices manufacturers have come forward to register with the concerned state licensing authorities for permission to manufacture the medical devices. Majority of the manufacturers are still doing this thriving business without proper license, sources said.

The 10 medical devices, which were brought under the purview of Drugs and Cosmetics Act, making it mandatory to get license for manufacture for sale and distribution are Cardiac stents, drug eluting stents, catheters, intra ocular lenses, IV cannulae, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.

The DCGI Dr Surinder Singh had recently warned the medical devices industry of action if it failed to obtain licences from the State licencing authorities and get them approved by the central authority. The DCGI’s action in this regard is to ensure quality in the medical devices industry.

(Ref: Chronicle Pharmabiz dated August 22, 2008)


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