No move to centralize WHO-GMP certification or to replace it with COPP, affirms DCGI

March 16, 2009, 0800 IST -Source : ePharmail of Pharmabiz.com. For more info, visit 
http://www.pharmabiz.com.

Seeking to end the prevailing confusion among the industry with regard to the WHO-GMP certification, the Drug Controller General of India (DCGI) has made it clear that there is no move to withdraw the system of WHO-GMP certification or replacing it with certificate of pharmaceutical products (COPP).

 

“The existing system would continue as it is and there is no move to disturb the pattern. We have not taken any decision with regard to discontinuing issuance of WHO-GMP certification or centralising the COPP,” DCGI Dr Surinder Singh told Pharmabiz, reacting to the recent media reports.

“The last DCC meeting actually took up the issue of framing uniform guidelines in this regard and has set up a sub-committee to study all the aspects and recommend guidelines. The effort is to put in place uniform guidelines for both the GMP and COPP. We will centralise the system only when we have sufficient staff strength to operate it smoothly, but not in the immediate future anyway,” he said.

There have been reports that the DCGI wanted to centralise the issuance of WHO-GMP certification system and replace it with COPP for pharma products, creating confusion and apprehension in the industry. Some of the industry associations have already met the DCGI to get clarification in this regard, following the media reports. The industry has also warned that if the system would be centralised, it would only delay the issuing of certificate as the CDSCO is still understaffed.

The DCGI has now categorically made it clear that the existing system of issuing WHO-GMP would continue in the same manner and the State licensing authorities would continue to issue the certificate after joint inspections by the CDSCO and the state drug control department.

He also said no instruction has been gone to the State authorities to withdraw the WHO-GMP certification. “I have clarified it to those industry delegations which met me as there was no decision at all. Only development on this aspect was the creation of the sub-committee by the DCC to study the issue of uniform guidelines,” he added.

WHO-GMP certificate is issued to manufacturing plants and COPP is issued for individual products and both of these are issued by the SLAs for two years. WHO-GMP certificate ensures the quality of a manufacturing unit while the COPP seeks to highlight the quality of the product. The effort by the authorities now is to bring uniform guidelines for both and ultimately centralise the entire system when there would be enough staff with the CDSCO, but will take long time for that.

CDSCO commences audits of onsite inspections of clinical trials

March 23, 2009, 0800 IST -Source : ePharmail of Pharmabiz.com. For more info, visit 
http://www.pharmabiz.com.

The Central Drugs Standard Control Organisation (CDSCO) has launched audits of ongoing clinical trials by the expert teams to ensure that they meet the desired norms although the draft guidelines are still being finalized to streamline the sector.

 

The CDSCO is also planning to make sure that all CROs get registered from June this year, after notifying the guidelines which are waiting for final clearance from the DCC and the DTAB with a view to take appropriate safeguards in the trials, sources said.

The special teams comprising drug inspector, pharmacologist and clinical trials expert are carrying out the onsite inspections to make sure that norms were adhered to. During the course of audits, being held for the first time in the country, glaring deficiencies have been found with several sponsors, monitors and CROs in complying with the protocols. Action will be initiated once the guidelines are finalized, it is learnt.

The authorities are also planning to cancel or suspend the licence for trials due to the discrepancies while enforcing the guidelines sternly. Another measure being planned is to make registration of CROs mandatory so that all the relevant information such as target audience can be brought into public domain. The basic norms for running the CROs have been drafted already by an expert panel with inclusion of industry representatives, officials and NGOs.

The expert panel, set up by the DCGI, had already carried out surprise checks on trial sites and urged for mandatory registration of CROs. The draft guidelines to monitor and regulate the sector are also being framed and would be put into force very soon, sources said.

US FDA and experts from Health Canada, facilitated by the WHO, have been giving necessary training to the officials of the CDSCO. They had already held a couple of workshops and conducted on-site visits along with Indian officials to give hands-on training to the drug inspectors.

The Indian clinical research segment is currently valued at USD 200 million and growing at 84 per cent annum. It would be a USD 1-billion industry by 2010.

SAVE LIVES: Clean Your Hands Update 1

Dear Colleague,

I am writing on behalf of the WHO World Alliance for Patient Safety’s First Global Patient Safety Challenge to update you on the progress we are making towards the extension to the Challenge programme, which is called SAVE LIVES: Clean Your Hands.

 We are launching this new initiative on 5 May this year and our aim is two-fold:

·          To have 5000 hospitals registered by 5 May 2010, taking the message of hand hygiene at the point of care to as wide a global health-care audience as possible.

·          To have all WHO member states pledged to hand hygiene by 2010 with country campaigns in place so that the pledge is translated from a country commitment to the individual patient.

The critical nature of health-care infections is such that we must galvanise action and to do this we need your support.

Already over 360 hospitals from 57 countries have registered their interest.  Registration is simple.  Just log onto this website
http://www.who.int/gpsc/5may/en/index.html
and follow the steps outlined.

 How can you help?

·          By registering your hospital

·          By inviting other hospitals in your region/country to register as well

·          By sending us information about progress on introducing hand hygiene that is being made in your hospital/country so that we can profile your good work on the website

 How can we help you?

·          By writing articles and updates for your newsletters and websites to further the spread of information.  Just let us know what you need and your deadline, and we will supply the details.

·          By updating the website (as above) on a weekly basis so that you can see the numbers of hospitals registering.  We are currently developing a map which will be identify the countries and WHO regions where hospitals register.

·          By updating the hand hygiene implementation toolkit.  This will be launched on 5 May 2009.

·          By developing a self assessment framework so that any hospital can assess its preparedness for hand hygiene via a 5-step tool.

·          By launching the new (revised) hand hygiene guidelines on 5 May 2009.

·          By developing hard copies of materials for hospitals in countries where internet access is difficult.  This will be done post 5 May.

 And finally, a reminder why hand hygiene in health care is so important!

·          At any one time over 1.4 million people worldwide are affected by health-care associated infections (HAI)

·          The risk in developing countries is 2-20 times higher than in developed countries.

·          Globally, there are about 59 million health-care workers = 10 million hands treating and touching patients, up to 15 times a day.

·          These hands can be the mediators of harmful microbes, each touch putting patients lives at risk.

 We invite YOUR participation in this new global initiative and look forward to hearing from you very soon. 

Yours sincerely,

Dr Cyrus Engineer

Project Lead

savelives@who.int

Blood banks of Fortis, Escorts get NABH accreditation

March 20, 2009, 0800 IST -Source : ePharmail of Pharmabiz.com. For more info, visit 
http://www.pharmabiz.com.

The blood banks at Fortis Hospital Noida (FHN) and Escorts Heart Institute and Research Centre (EHIRC) have been awarded the National Accreditation Board for Hospitals and Healthcare Organizations (NABH) accreditation from the Quality Council of India (QCI). The blood banks at FHN and EHIRC are among the seven NABH accredited blood banks in India. The NABH standards for blood banks provide framework for quality assurance and quality improvement for blood banks. The soul focus of the standards is to maintain high end patient safety measures and quality of the care being provided. The QCI follows a continuous process where regular monitoring and stringent corrective action plan leads to the building of a strong culture at all levels of operations and functions. The standards are applicable to blood banks in the government as well as private sector. “There has been a growing concern on how accessible and safe is ‘Safe Blood’. The Indian government is also laying stress on state-of-the-art blood bank facilities at every hospital either in the private or public sector healthcare centres. To maintain the standards in the quality of blood bank services and safe blood banking, it is desirable that a blood bank is accredited from a national or international governing organization like QCI,” said Dr Narottam Puri, president-medical strategy and quality Fortis Healthcare Limited. “QCI conducted rigorous quality and standard checks for seven months at both the hospitals and after complete the process successfully the accreditation was awarded to both the blood banks. Fortis Healthcare’s team is proud of its transfusion services for providing critical and life saving support to our patients,” he said in a release here.