CDSCO team recommends health ministry to cancel registration of one unit in China

June 27, 2012 by · Leave a Comment
Filed under: Manufacturing Industry Updates 

CDSCO team recommends health ministry to cancel registration of one unit in China
June 26, 2012, 0800 IST – Source : Pharmabiz News

The three-member team of the Central Drugs Standard Control Organization (CDSCO), which had audited four manufacturing units in China in February this year, had recommended to the union health ministry to cancel the registration of at least one of these units as it was not found in proper condition.

The three-member delegation, consisting of Dr S Eshwar Reddy, assistant drug controller, CDSCO New Delhi; B Kumar, assistant drugs controller, CDSCO sub-zonal office (Chandigarh) and Dr C Sokhey, senior scientist at National Institute of Biologicals (Noida), inspected a total of four manufacturing units in China, during their visit to China from February 11 to 22 this year. They had inspected three API units and one diagnostics unit.

According to sources, the CDSCO team has submitted its detailed report to the health ministry in which it has recommended to cancel one unit as they have found several anomalies in the unit. However, the official refused to reveal further details.

This is the second time that the Union health ministry has sent its team to China for auditing and inspection of manufacturing units there. As part of its efforts to ensure that only quality products are sourced by Indian companies from abroad, the health ministry had earlier last year started the process of auditing and inspection of manufacturing plants outside India. The first delegation was sent to China in May last year in which the delegation had inspected five manufacturing units there. Though the delegation was to inspect six units, one unit did not allow the delegation to inspect their unit.

The introduction of auditing and inspection of foreign manufacturing facilities by the Indian drug regulators was a long awaited practice, especially in the wake of the fact that even though the government had made registration of imports of drugs and pharmaceuticals into India made mandatory way back in 2003, it failed to bring the desired results as the inflow of inferior raw materials into the country refused to subside.

It was under this background that the ministry earlier last year decided to introduce the practice of inspection of foreign manufacturing facilities.

During the second delegation, the inspections were carried out in China only and the plans to inspect manufacturing plants in Italy has again been deferred. Earlier, the ministry had elaborate plans to start the new practice with one country each in Europe and Asia — Italy in Europe and China in Asia.

 

Parliamentary panel to meet stakeholders on National Commission for Human Resources for Health Bill

June 27, 2012 by · Leave a Comment
Filed under: Uncategorized 

Parliamentary panel to meet stakeholders on National Commission for Human Resources for Health Bill
June 26, 2012, 0800 IST – Source : Pharmabiz News

The Parliamentary Standing Committee on Health and Family Welfare, currently examining the National Commission for Human Resources for Health Bill (NCHRH Bill), is planning to meet different stakeholders for wider consultations. The Committee is planning to finalise the recommendations soon and to submit them before the House during the next Session.

The Parliamentary panel had received inputs from different sections and was examining them before scheduling meetings with the stakeholders for extensive and ‘in-depth’ consultations before finalizing the recommendations to be submitted to the Parliament. Once fixed, the schedule of the meetings will be intimated to the stakeholders, sources said.

The NCHRH Bill, 2011 seeks to consolidate the law in certain disciplines of health sector and promote human resources in health sector and provide for mechanism for the determination, maintenance, co-ordination and regulation of standards of health education throughout the country to ensure adequate availability of human resources in all the States.

The Bill was introduced in Rajya Sabha on December 2011 and was referred to the Department-related standing committee headed by Brajesh Pathak for examination and report. The panel had invited suggestions and comments from the interested groups and individuals on the Bill. It got several representations already, sources said.

It also seeks to establish the NCHRH and to supervise and regulate professional Councils in various disciplines of health sector and for matters connected therewith or incidental thereto.

“The Commission will carry out studies and collect data required to assess the needs and requirements of human resources for health in different States and Union territories; assess the requirement (including the number, type and geographical location) of health training facilities for education and training in medical and allied discipline; formulate action plans for development of human resources for health in accordance with the policy and priorities laid down by the Central Government from time to time; formulate a plan for financial and other resources required for creation of human resources; make recommendations on the measures to strengthen the healthcare delivery, operational efficiency and healthcare infrastructure; coordinate existing healthcare infrastructure in Central and State Government for effective utilisation thereof; and regulate, in accordance with the law, for the time being in force, the entry and operation of foreign health educational institutions if permitted under the law for the time being in force in consultation with the Board or such other authority as may be specified by the Central Government,” according to the Bill.

Health Ministry revives steps to table pending bill on medical devices in monsoon session

June 27, 2012 by · Leave a Comment
Filed under: Medical Devices 

Health Ministry revives steps to table pending bill on medical devices in monsoon session

June 27, 2012, 0800 IST – Source : Pharmabiz News

 The Health Ministry has initiated steps to push the long pending bill on medical devices with the consent of the States and hopes to table it in the Parliament during the monsoon session. The Ministry held a meeting recently with stakeholder associations like FICCI and the Association of Indian Manufacturers of Medical Devices, apart from the senior officials from the Central Drugs Standard Control Organisation (CDSCO) to discuss the issue. In the face of continuing opposition from some States, the meeting decided to follow up the activities to secure the assent of all the States, sources said. Besides, the Ministry is also reportedly under pressure from Prime Minister’s Office to table the bill in the Parliament at the earliest so that the growing medical devices sector would get a much needed impetus in the form of regulatory mechanism. “The proposed amendment to the Drugs and Cosmetics Act (D&C Act) will lay down separate provisions for Medical Devices. The salient features of the bill would be to provide a separate definition of Medical Devices, their risk based classification for regulatory control, Clinical Trials on Medical Devices, Conformity Assessment Procedures, Penal provisions, etc.,” sources said. Currently, medical devices are treated as drugs. With only 14 notified devices regulated under the D&C Acts, thousands others remain unregulated in the country. The industry, which opposed the moves to increase the number of devices under regulation, wanted separate guidelines and definition for medical devices. Meanwhile, many States are still opposed to the bill but assent of all the States are required as health is under the concurrent list. The Ministry had circulated the draft among the States, after revising it on the basis of the recommendations by the Parliamentary Standing Committee attached to the Health Ministry. The bill has been pending now for over four years. Hoping that the bill will go to the Parliament during the monsoon session, the ministry had already sought Rs. 205 crore from the Planning Commission to set up regulatory mechanism for the sector during the next Five Year Plan period.

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