Govt constitutes National Apex Committee for monitoring stem cell research

Govt constitutes National Apex Committee for monitoring stem cell research
October 16, 2009, 0800 IST – Source : Pharmabiz News The Union Health Ministry has finally constituted the much awaited National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) for effectively reviewing and monitoring the stem cell research in the country. Dr Mammen Chandy of Christian Medical College (CMC), Vellore will be the chairman of the committee.

 

Official sources said that a high-powered committee, consisting of senior officials like secretary Department of Biotechnology (DBT) Dr MK Bhan and ICMR director general Dr VM Katoch, has selected Dr Mammen Chandy as chairman of the committee. The government has already sent letters to Dr Chandy and other members of informing the government decision. Once they accept the offers, the government will announce the much awaited committee.

The NAC will have around 10 members headed by a chairman and will have members from different fields. The chairman will be assisted by deputy chairman, member secretary and nominees from DBT, DST, CSIR, ICMR, DCGI, DAE, and biomedical experts drawn from various disciplines like pharmacology, immunology, cell biology, haematology, genetics, developmental biology, clinical medicine and nursing. There will be a legal expert, social scientist, and a women’s representative in the NAC. In addition consultants/experts could be consulted for specific topics and advice.

It will be a multidisciplinary body with a secretariat which will have two main functions: general oversight and policy monitoring function; and to review specific controversial or ethically more sensitive research proposals. The committee will have the responsibility to examine the scientific, technical, ethical, legal and social issues in the area of stem cell based research and therapy.

All institutions involved in any type of stem cell research and therapy shall be registered with the NAC. Once the Apex Committee is in place, all institutions and investigators, both public and private, carrying out research on human stem cells should be registered with the NAC through Institutional Committee for Stem Cell Research and Therapy (IC-SCRT).

The NAC will set up standards for safety and quality, quality control, procedures for collection and its schedule, processing or preparation, expansion, differentiation, preservation for storage, removal from storage to assure quality and/or sterility of human tissue, prevention of infectious contamination or cross contamination during processing, carcinogenicity and xenotransplantation.

The constitution of NAC-SCRT is a significant step by the government as the area of stem cell research is new and is associated with rapid scientific developments and complicated ethical, social and legal issues. So, it requires extra care and expertise in scientific and ethical evaluation of research proposals in the area of stem cells.

AHHACON 2009

AHHACON (Association of Health & Hospital Administrators), Hyderabad is conducting AHHACON 2009 in Narayana Medical College Hospital, Nellore in Andhra Pradesh. The event is scheduled for 28th & 29th of November 2009.

Who can attend this event ?

Directors, CEOs, COOs, Planners, Policy-makers of hospitals and nursing homes, Healthcare Consultants, Medical Superinten-dents, Hospital Administrators, Health care Professionals, Resident Medical Officers, Post-graduate residents, Postgraduate students of Hospital and Healthcare Administration and Management and all persons involved in the health care management.

Event Topics :

How to reach Nellore? Nearest Airports are Tirupathi(120km) & Chennai (175km).

By Air:

By Rail:

By Road:

Contact :

Dr M Veera Prasad, MD (HA), DNB, MNAMS
Organising Secretary, AHHACON ‘09
COO and HOD, Dept of Hosp Admn
Narayana Medical College & Hospital
NELLORE – 524 002 (AP), INDIA.
Mobile# 0 99490 77088,,,,,,,,0 94910 42939
www.narayanamedicalcollege.com

 

On NH-5 between Vijayawada & Chennai Nellore railway station is on main line between Vijayawada & Chennai

1. Green hospitals & hospital planning
2. Recent advances in management of HAI
3. CRM/SCM/RCM
4. Medical errors & patient safety
5. Operations research in hospitals
6. Quality initiatives in healthcare
7. Accreditation – ISO, NABH, JCI
8. Management of medical education institutes
9. HR challenges in healthcare
10. Managing change conflicts
11. Healthcare scenario in North-East
12. Legal obligations in hospital operations
13. Challenges in public health

Some Eminent Speakers , PGIMER, Chandigarh

Prof.A.K.Gupta

Prof.R.K.Sharma

Prof.Anil Gomes

Dr.Nitish Shetty

Dr.S.Manivannan

Mr.Samuel NJ David

Prof.B.V.Subramanyam

Dr.S.Vijay Kumar

Ms.Ala Shankeran

Lt.Col.D.P.Saraswath

Prof.P.Sathyanarayana

(Col)Prof.Dayakar.T

Prof.Masood Ahmed

, Deccan School of Mgmt , Consultant, HMRI, Hyd , ICRI, Hyderabad , Max Health Care, Delhi , Global Healthcity, Chennai , NMCH , NMCH , CMC, Vellore , ED, KMC, Trichy , CEO, Narayana Hrudayalaya , MAHE, Manipal , DGHS, Govt. of Assam

Clinical Establishments Bill 2007 expired, redrafted for tabling in next Session

Clinical Establishments Bill 2007 expired, redrafted for tabling in next Session
November 10, 2009, 0800 IST  – Source : Pharmabiz News 

A redrafted bill, in the place of the already lapsed Clinical Establishments (registration and regulation) Bill 2007, to introduce mandatory registration of all healthcare establishments is likely to be tabled in the next Parliament session.

After almost a year, the Health Ministry is learnt to be drafting the new bill incorporating many of the recommendations by the Parliamentary committee and is expected to be ready with it soon. The original bill, which was introduced two years back and went to the scrutiny of the committee, has already been lapsed, sources said.

The new Healthcare Establishments (registration and regulation) Bill will have an expanded purview unlike in the previous bill which sought to cover only clinical establishments. The laboratories, diagnostic services, R&D facilities taking up clinical trials on patients and all systems of medicines will be included for compulsory registration in the new bill, it is learnt.

Sources said the finalization of the Format, for provisional registration of institutions, which has been pending for some time, was being done so that it can be introduced soon after the passage of the bill. The department has received many feedbacks from the stakeholders and experts on the proposed format.

The word clinical is being changed in the title of the bill as there is an impression that it covers only allopathic clinics and under the new bill, entire gamut of healthcare services will be included. It will also cover OPD services as even surgical interventions were done these days without patient’s stay in the hospital or nursing home, sources said.

However, it is not known whether the bill will have purview over the government hospitals as recommended by the Parliamentary panel. “The committee does not find any substance in exclusion of Government/public health institutions/ autonomous institutions from the purview of the Act as put forth before it through some representations,” the committee had said in its report.

ISO 15189 & ISO 9000- ILAC Announcement

Medical laboratories accredited to ISO 15189:2007 (a sector-specific technical competence and management system standard) are recognized as meeting the management system principles of ISO 9001:2008. The move was announced in a joint communiqué by ISO (the International Organization for Standardization), ILAC (the International Laboratory Accreditation Cooperation) and the IAF (the International Accreditation Forum) in September 2009. The ISO-IAF-ILAC communiqué was issued to address the misconception in the market that medical laboratories accredited to ISO 15189:2007 do not operate a recognized management system. Until now, accredited medical laboratories were often requested by their customers to undertake the additional step of certification to ISO 9001:2008 to demonstrate that they are in full control of their processes. Based on the new procedures, medical laboratories accredited to ISO 15189 will now be recognized as meeting the management systems principles of ISO 9001:2008. Accredited medical laboratories that are part of a larger organization certified to ISO 9001 should only need to be assessed once according to ISO 15189, and these results accepted as meeting the principles of the management system requirements (ISO 9001:2008). This recognition will reduce redundant, costly and time-consuming audits and, at the same time, enable medical laboratories to better meet their customers’ needs.

CTRI to keep tab on human studies, may eliminate unethical practices during trials

CTRI to keep tab on human studies, may eliminate unethical practices during trials
July 21, 2009, 0800 ISTBy making registration of human trials mandatory from June 15, 2009, clinical research has become more accountable in the country. The measure by the Drugs Controller General of India (DCGI) office is expected to bring more transparency to this critical part of drug research. Clinical research organizations have positively responded to the compulsory registration as it can also curb malpractices in human trials.

 

The trials have to be registered by any one of the stakeholders: sponsors/CRO/Institutions/Investigators/Ethics Committee. If a trial is not registered, volunteers or patients cannot be recruited. Clinical Trials Registry- India (CTRI) is recording every study taking place in India along with details of new drugs, therapies, surgical procedures and medical devices.

The issues of credibility, quality and reliability of the trial are critical for India as the country is carrying out over 700 human studies. This has also put pressure on DCGI to raise the benchmark of Indian clinical trials industry which is currently valued at $1.58 billion with 120 CROs. Some of the CROs are independent entities while others are attached to hospitals.

This was a much awaited regulation in this sector. There is no room for fraud, chaotic and disorganized work process. “We now need to see how exactly DCGI will monitor the CROs through the CTRI,” stated Dr Ramananda Nadig, president and deputy dean, Clinical Research Education and Management Academy (CREMA).

The registration of clinical trials not only will streamline human studies in India but it compliments the clinical trial governance like that of the US. With a strict regime enforced, CTRI has automatically created a paradigm shift in the conduct of clinical trials. From stringent adherence to quality standard operating procedures, qualified-trained principal investigators and well equipped sites, every CRO is now gearing up to ensure the parameters are achieved, stated Shekhar Gupta, chief operating officer, D2L Pharma Research Solutions.

CTRI registration is a license to conduct a trial. Global companies will have the added confidence and no longer show restraint and apprehension to off-load human studies to India, added Gupta.

According to Dr KH Ram, managing director, SMO Clinical Research (I) Pvt Ltd, the CTRI is viewed as platform to eliminate unethical practices. This dedicated registry to monitor clinical trials was the best thing that could happen. The focus is only on ensuring ethical practices and patient safety which are the cornerstones of success for a CRO.

The need for regulation in this sector was felt ever since deaths were reported during clinical trials at reputed medical centres in the country. As India has emerged as a hub for clinical trial, a credible regulatory framework was needed to enhance the growth of this industry. The registry will improve the country’s image which has been tarnished with cases of alleged unethical and sub-standard practices during the conduct of clinical trials.

On-site inspection of clinical trials to be intensified by CDSCO teams soon

On-site inspection of clinical trials to be intensified by CDSCO teams soon
July 21, 2009, 0800 IST – Source : Pharma Biz NewsAs part of the measures to tighten regulations in the clinical trials sector, the specially assigned Central Drugs Standard Control Organisation (CDSCO) teams will intensify the on-site inspections of trials after a number of recent inspections have exposed various good clinical practices violations.
Following the inspections by the expert teams from the CDSCO in the recent past, investigator, sponsors and monitors of the trials were issued warning letters in a few cases so far for violating the Good Clinical Practice (GCP) norms, sources said without identifying the names of Contract Research Organizations (CROs). In one case, the CRO had taken corrective measures while some trials are still under suspension.

 

“The clinical trial remained suspended at all the 12 sites of one CRO from November 6, 2008 to April 22. The inspection was held only one of their sites. The sponsor submitted various corrective actions taken to ensure GCP compliance. CDSCO scrutinized the same and decided to revoke the suspension on April 23 from all the sites except the inspected site. Further investigator of the inspected site also submitted details of corrective actions taken by them, based on which the suspension from the inspected site was also revoked on in June,” a senior official said.

According to the Drugs Controller General of India (DCGI) office, the inspections would now be intensified across the country and special official teams including experts have been designated for the purpose in different CDSCO zones. Though only warning letters were issued in the cases so far to begin with and giving them chance to correct the faults, more stringent action including withdrawal of licences will be taken in case of future violations and serious lapses.

The CDSCO had taken a number of steps to streamline the sector and has prepared draft guidelines to be included as Schedule Y-1 which stipulates registration of CROs. The draft rule mandates that the CROs should undertake a declaration which reads, “We shall allow the licensing authority and/or any person authorised by him in that behalf to enter and inspect the premises and to examine the process/procedure and documents in respect of any clinical trial conducted by us for which the registration certificate has been made.” The draft rules further clarifies that the licensing authority would suspend or cancel the license of the organisation if the latter fails to comply with the conditions of registration and the CRO has to appeal to the central government within 90 days of the receipt of the copy of the order.

Centre releases draft rule for Schedule Y-1 mandating registration of CROs

Centre releases draft rule for Schedule Y-1 mandating registration of CROs

July 11, 2009, 0800 IST – Source : Pharmabiz News

The Drug Controller General of India (DCGI) has released draft rules for registration of clinical research organisations (CROs) mandating strict adherence of standard operating procedures by the individuals, institutions or organisations conducting clinical trials in the country.

As per the draft rule, to be included in the Drugs and Cosmetics Act, 1945, as Schedule Y-1 and with the title Rule 122 DAB, the CROs can carry out its activities according to the contract with the sponsor only if it is duly registered, under the rules, by the Licensing Authority defined in Clause

(b) of Rule 21.

The guidelines cover all organisations, individuals, institutions and companies that take the responsibility of the initiation or management or coordination of a clinical trial even as the clinical trial sites are exempted from registration. The organisations have to submit an application for the registration with the information as required under Schedule Y-1, for the approval from the licensing Authority.

The validity of registration is fixed for a period of five years from the date of issue, unless the regulatory authority has not suspended or cancelled the approval within the said time, explains the draft rule approved by the Drug Technical Advisory Board (DTAB). The DCGI has informed the interested parties to file their response with the drug regulator within a period of 45 days from the period of publication of the draft rules.

India is the first country in the world to come up with such registration criteria for CROs, informs industry experts. “This is a good move from the DCGI’s part to ensure the global pharma industry and the general public that the clinical trials conducted in the country is now strictly monitored by us. From an industry perspective, it doesn’t affect us any way unless intend is not manipulated,” said Dr Arun Bhatt, a well-known clinical research expert and president, ClinInvent Research Pvt Ltd.

However, he added that the declaration to be filed by the organisations for registration, which agrees that it should allow surprise inspections by the licensing authority in the clinical trial premises may create some problem, is not implemented in goodwill.

The draft rule mandates that the CROs should undertake a declaration which reads, “We shall allow the licensing authority and/or any person authorised by him in that behalf to enter and inspect the premises and to examine the process/procedure and documents in respect of any clinical trial conducted by us for which the registration certificate has been made.”

The draft rules further clarifies that the licensing authority would suspend or cancel the license of the organisation if the latter fails to comply with the conditions of registration and the CRO has to appeal to the central government within 90 days of the receipt of the copy of the order.

The central government has the final authority to confirm, reverse or modify such order, after giving an opportunity of being heard.

The guideline also mandates the CROs that all records like written documents, electronic, magnetic or optical records and scans such as protocols, approvals from the Central Drug Standard Control Organisation

(CDSCO) and ethics committee, investigators’ particulars, consent forms, monitor reports, audit certificates, relevant letters, reference ranges, completed and the final reports, shall be maintained and strict confidentiality has to be observed during access and retrieval procedures.

National Apex Committee for monitoring stem cell research to be set up soon

National Apex Committee for monitoring stem cell research to be set up soon

July 15, 2009, 0800 IST – Source : Pharmabiz News

The Union health ministry will constitute the much awaited National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) for effectively reviewing and monitoring the stem cell research in the country. “All formalities for the constitution of the NAC are complete and it will be announced in a day or two”, a senior ICMR official said.

ICMR sources said that the NAC will have around 15 members headed by a chairman and will have members from different fields. The chairman will be assisted by deputy chairman, member secretary and nominees from DBT, DST, CSIR, ICMR, DCGI, DAE, and biomedical experts drawn from various disciplines like pharmacology, immunology, cell biology, haematology, genetics, developmental biology, clinical medicine and nursing. There will be a legal expert, social scientist, and a women’s representative in the NAC. In addition consultants/experts could be consulted for specific topics and advice.

It will be a multidisciplinary body with a secretariat which will have two main functions: general oversight and policy monitoring function; and to review specific controversial or ethically more sensitive research proposals. The Committee will have the responsibility to examine the scientific, technical, ethical, legal and social issues in the area of stem cell based research and therapy.

All institutions involved in any type of stem cell research and therapy shall be registered with the NAC. Once the Apex Committee is in place, all institutions and investigators, both public and private, carrying out research on human stem cells should be registered with the NAC through Institutional Committee for Stem Cell Research and Therapy (IC-SCRT).

The NAC will set up standards for safety and quality, quality control, procedures for collection and its schedule, processing or preparation, expansion, differentiation, preservation for storage, removal from storage to assure quality and/or sterility of human tissue, prevention of infectious contamination or cross contamination during processing, carcinogenicity and xenotransplantation.

The constitution of NAC-SCRT is a significant step by the government as the area of stem cell research is new and is associated with rapid scientific developments and complicated ethical, social and legal issues. So, it requires extra care and expertise in scientific and ethical evaluation of research proposals in the area of stem cells.

 

Medical devices sector seeks abolition of List 37 to help domestic units

Medical devices sector seeks abolition of List 37 to help domestic units
July 04, 2009, 0800 IST – Source : Pharmabiz NewsWith the finance minister Pranab Mukherjee is all set to present his budget on July 6, the Association of Indian Medical Device Industry (AIMED) is hoping that some measures would come through to protect the interest of the hugely potential sector which has been ignored continuously in the previous budgets.

 

“The medical device market which is currently mainly import dependent needs a special focus and infrastructure development status at least for the next four years. In order to make the Indian industry globally competitive, there is a need for a holistic development and to regulate the industry for which Inter-ministerial coordination is required between the Ministries of health, finance and science and technology,” AIMED principal forum coordinator Rajiv Nath said.

In a recent representation, AIMED has pleaded with the government to consider creation of a new Medical Export Promotion Council to promote export and to check custom impasse on the border. It suggested that the name of Pharmaceuticals Export Promotion Council should be changed into Medical Export Promotion Council for enabling the inclusion of lab ware, diagnostics and medical tourism with medical devices. Medical devices are not medicines, so it should be treated as a separate industry.

AIMED had appealed to the ministry for the abolition of List 37 which consists 111 medical and surgical instruments and appliances. Abolition of List 37 will encourage development of domestic industry.

According to this List, duty on import of components is higher than imported finished devices. This marks a huge loss for the indigenous industry and inhibits growth of Indian manufacturers. Importation of Blood Collection Tube (BCT), used for collection of blood for testing, attracts a custom duty of 7.5 per cent while import of components i.e. glass tube and cap fall under custom duty at 10 per cent which is higher than the finished product. In order to develop the indigenous market, the rate of custom duty on BCT as finished product must be increased from 7.5 per cent to over 10 per cent and custom duty on imported components should be reduced from 10 per cent to 5 per cent, the association said.

AIMED is an apex umbrella association of 700 manufacturers producing a wide range of products like medical disposables, medical diagnostics, medical electronics and medical equipments and implants.

 

DCGI order makes 100 more entries into Trial Registry in one month

DCGI order makes 100 more entries into Trial Registry in one month

July 20, 2009, 0800 IST – Source : Pharmabiz News

The directive by the DCGI to get all new clinical trials registered with the Clinical Trial Registry-India (CTRI) as a pre-requisite for obtaining permission has made a notable impact. Around 100 trials were registered during last one month alone after it was made compulsory from June 15 by the CDSCO, the sources said. As many as 342 trials have been registered in the site so far. Interestingly, the total number of trials registered from July 2007, when it was launched by the Indian Council of Medical Research (ICMR), to December 2007 was just 11. During 2008, the number went upto 137, still far from the desired level given the size of the clinical trials going on in the country. From January 2009 to July 16, the total number of trials registered was 194. Interestingly, around 100 of them came during the last one month alone, indicating a reasonable compliance to the DCGI directive aiming at streamlining the trial sector in the country, sources in the ICMR said. “The impact is tremendous. All these trials in the site were registered after quality check. Every day we are getting 20 to 30 applications. Some may not be having all required information and we want to put them only after all clearing all doubts and it takes time. We are in the process of upgrading the software to make it automatic, instead of manual checking of the quality parameters,” ICMR official in-charge of the CTRI told Pharmabiz. The CDSCO had made registration of all clinical trials mandatory in the ICMR Trial Registry with effect from June 15, as part of streamlining the trials sector which has been largely unregulated. Accordingly, while granting permission for clinical trials, applicants are now being informed that registration of clinical trial in ICMR Registry www.ctri.in before its initiation will be mandatory from June 15, 2009. ICMR sources said site had implemented all required norms set by the WHO. But, more things should be done with regard to the speed of the internet and software which would be taken care soon. Then every month, it would be reviewed and status report would be made. However, there is no mechanism at present to submit regular reports to the CDSCO or the DCGI office was not asking for the same.