Roundtable on Delayed Payments to MSMEs

Dear Sir,

                                               Roundtable on Delayed Payments to MSMEs

1500 hrs on 5 March 2012 : The Mantosh Sondhi Centre, 23 Institutional Area , Lodhi Road, New Delhi.

Delayed payment is a major concern for MSME’s and the major cause forsickness in the MSME’s sector is delayed payments. The MSMED act 2006 provides for penal interest on the delayed payment beyond 45 days, however, this has not helped the MSME is any way. CII has always accorded high priority to MSME sector and proactively addresses the issues of Delayed payments for the MSMEs.

With this Background ,CII is organizing a  Roundtable on Delayed Payments to MSMEs, at 1500 hrs on 5^th March 2012 2011 atThe Mantosh Sondhi Centre, 23 Institutional Area , Lodhi Road, New Delhi . 

A senior official from Ministry of MSME, Government of India will interact with MSME entrepreneurs.

I am writing to request you and your colleagues to kindly attend the Roundtable on Delayed Payments to MSMEs and send your confirmation, in the reply form given below.

We look forward to your kind confirmation.

Regards,

Gurpal Singh

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Principal Advisor and Head – MSME

Confederation of Indian Industry

Plot No 249 F, Sector 18, Udyog Vihar, Phase IV

Gurgaon – 122 015 (Haryana, India)

Tel: +91-124 – 4014539,Fax:+91-124 – 4014057/4014080

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REPLY FORM

Himanshu Dhingra 

Confederation of Indian Industry

249-F, Sector 18, Udyog Vihar, Phase IV

Gurgaon 122015

Tel : 0124 – 4014053 Fax :0124 – 4014080

Email: Himanshu Shingra

                                          Roundtable on Delayed Payments to MSMEs

1500 hrs on 5 March 2012 :  The Mantosh Sondhi Centre, 23 Institutional Area , Lodhi Road, New Delhi.

 

 

A] I would attend (  )

 B] I would not attend (  )

  

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Health ministry’s efforts to make registration of BA/BE studies mandatory with CTRI stuck in red-tapism

Health ministry’s efforts to make registration of BA/BE studies mandatory with CTRI stuck in red-tapism
February 06, 2012, 0800 IST – Source : PharmaBizNews

The union health ministry’s efforts to make the registration of bioavailability and bioequivalance (BA/BE) studies mandatory with the Clinical Trial Registry of India (CTRI) are stuck in the bureaucratic red-tapism as different departments of the ministry are passing the buck on funding the project.

According to sources in the the National Institute of Medical Statistics (NIMS), which has been given the responsibility to make the necessary changes in its web network to incorporate the BA/BE features, the NIMS could not take up the project so far as no funding has come from the ministry.

Though the then Drugs Controller General of India (DCGI) Dr Surinder Singh had asked the NIMS to get the funding for the project from Indian Council of Medical Research (ICMR), the ICMR is yet to the provide any funding to NIMS for the project. “We are waiting for funds. The moment we get the funding, we will start the project,” a senior official said.

Earlier, after more than two years since the registration of clinical trials was made mandatory in the country, the health ministry had taken the decision in-principle to make the registration of BA/BE studies mandatory, on the same lines of the other clinical trials in the country. The then DCGI Dr Surinder Singh had directed the senior officials in the CTRI to make the necessary changes in its web network to incorporate the BA/BE features.

According to sources, the ministry wanted to streamline the BA/BE studies in the country. So far, registration of BA/BE studies with the CTRI was optional. Once it is made mandatory, all the BA/BE studies have to be registered with the CRTI without which the DCGI will not give permission to conduct BA/BE studies which are conducted on healthy volunteers.

Hundreds of BA/BE studies are going on at any given time in the country at different clinical research centres. BA/BE studies which take about three months time, are conducted for finding the bioavailability and bioequivalance of a drug, especially the generic drugs and the combination drugs which are already in the market. For getting the license for a new combination drug or generic drug, it is mandatory to submit the BA/BE study results to the DCGI office.

 

Health ministry tightens norms on clinical trials, action on two violations

January 25, 2012, 0800 IST – Source : PharmaBizNews

The Union health ministry has tightened the norms on clinical trials after amending necessary rules regarding obtaining informed consent from the trial subjects and extending financial assistance to the victims, and has found two cases of violations in trials in the recent past.

The two cases came to the notice of the Drug Controller General of India (DCGI) were about the trial of drug Tadalafil in a hospital at Indore and the trial of an anti-cancer drug by Axis Clinical Research, Hyderabad, prompting the authorities to take action, sources said.

The DCGI initiated action following report t in respect of allegedly flouting of clinical trial norms at Maharaja Yashwant Rao Hospital and Mahatma Gandhi Memorial College, Indore where the drug Tadalafil was used for clinical trial for Pulmonary Arterial Hypertension (PAH).

“The office of DCG(I) directed CDSCO (WZ) on 12-07-11 to carry out a investigation to ascertain the facts. Accordingly an investigation was carried out by the office of CDSCO(WZ) and State Drugs Controlling Authority on 10-08-11 in respect of clinical trials conducted at M G M Medical college and associated M Y Hospital in Indore. As per the investigation report, a trial was conducted by Dr Anil Bharani and Dr Ashish Patel with tadalafil in patients with group-1 pulmonary hypertension without permission from DCG(I),” sources said.

“The study with Tadalafil was initiated on 18-09-05 when the drug was not approved for the said indication in the country. However, the drug was approved in the country for another indication – male erectile dysfunction on 10.06.2003. In view of above, vide letter dated 02-11-11 directed both the doctors namely Dr Anil Bharani and Dr Ashish Patel to stop the clinical trial of Tadalafil in Pulmonary Arterial Hypertension and restricted them to conduct any clinical trial for a period of six months,” sources said.

Another case that attracted action from the authorities was the trial of an anti-cancer drug by Axis Clinical Research, on poor people without proper informed consent. The investigations revealed that the firm conducted bioequivalence study on an already approved anticancer drug and there were certain irregularities with respect to informed consent process, review and decision making process of Ethics Committee.

“The permission granted to the firm for conducting bioequivalence and bioavailability study was suspended on 22.06.2011. Consequent to this, the firm, on 04.07.2011, has submitted corrective actions being taken by them including revised Standard Operative Procedures (SOP’s) for subject recruitment process, informed consent process, review and decision making process of the Ethics Committee. Based on further investigations and verifications, Axis Clinical Research, Hyderabad was granted ‘NOC’ to conduct Bio-equivalence study  subject to fulfillment of various condition regarding Informed Consent Process including documentation of the Informed consent process through Audio-Video means, functioning of Ethics Committee and investigators,” sources said.

In order to strengthen the regulations relating to clinical trials, following proposals  for amendments in Drugs and Cosmetics Rules, 1945 have been  approved by Drug Technical Advisory Board (DTAB) and a draft notification was published some time back to incorporate effective provisions for providing financial compensation to the trial subjects in case of trial related injury or death.

Another step in this regard was enhancement of responsibilities of Ethics Committee, Sponsor & Investigator to ensure that financial compensation as well as medical care is provided to the trial subjects who suffer trial related injury or deaths. Amendment was also made on the format for obtaining informed consent of trial subjects to include the details of address, occupation, annual income of the subject so as to have information regarding socio-economic status of the trial subjects.

Virtue Insight to organise ‘Clinical trials Asia summit-2012′ on February 9 in Mumbai

January 27, 2012, 0800 IST – Source : PharmaBizNews

Virtue Insight, Tamil Nadu will organise the 3rd Annual Clinical Trials Asia Summit 2012 – “A critical guide for successfully conducting clinical trials” on February 9 in Mumbai.

The summit aims to provide a detailed analysis of what it takes to conduct clinical trials from a biopharmaceuticals and vaccines perspective in India and China and also addressing risk/benefit balance, anecdotal experiences of the MNCs in India and China, selection and role of CROs, logistics of operations, clinical trials management, government policies and pharmacovigilance.

This summit will target IPOs, generic pharmaceutical companies, CROs, patient recruitment companies, Government- Department of Health, non-profit organisations/ association, academics and consultants.

The key speakers present at the event includes: Arun Bhatt, president, Clininvent Research; Deven Parmar, vice president – Global Clinical Research; Arani Chatterjee, senior vice president, Clinical Research, Panacea Biotec; D Roy, deputy drugs controller (India), CDSCO – North Zone; R H Jani, senior Senior Vice President, Clinical R&D, Cadila Healthcare; etc.

The summit will examine the current issues faced in clinical trials operations, addressing the risks, timeline and budget stipulations, while effectively tackling key challenges in overcoming trials agreement and site contract arbitration problems. It will also discuss the operational element of trial site management, strategic partnership with CROs and SMOs, patient, talent and investigators management in order to improve and optimise the overall drug development effectiveness and ROI. The summit will help to discover on how to implement and benefit from electronic data management & monitoring cost effectively.

Some of the key themes to be discussed at the summit include: overview of Indian healthcare and clinical trial system towards 2013, discovering the new trends in global clinical trials and their role in India, strategies to conduct successful interventional oncology trials in India, future expectations of regulatory authorities and the type of regulatory structure present in India, challenges faced in regulatory approval processes, regulatory review at the DCGI and CDSCO, etc.

Informed consent and compensation to victims set to drive more volunteers and patients for clinical trials

 January 28, 2012, 0800 IST – Source : PharmaBizNews

The Union government’s stringent regulations on seeking informed consent and providing compensation to clinical trial victims would increase the number of volunteers and patients going for a trial in India, according to experts.

According to Dr Bhanu Priya, director and head, clinical research, G7 Synergon Life Sciences Consulting, the clause of compensation has now been insisted and therefore it is an assurance for the patients and for clinical research organizations to participate in human study and carry out the trial respectively.

Although Schedule Y of the Drugs and Cosmetics Act (D&C Act) called for compensation, Clinical Research Organizations (CROs) took up insurance policies to protect the patient in the wake of an adversity. But now with the amendment in the Act, the compensation cannot be ignored. There have been several insurance players who have chipped in to support the CROs with a dedicated policy. These include National Insurance, Oriental Insurance and  Metflife, to name a few.

There is no doubt that both informed consent and compensation to victims are the two key factors which are giving the Indian volunteers and patients the confidence of participating in a clinical trial. While the former helps the volunteer or patient to understand the risks of the human study, the latter provides the much needed financial and medical support if the medicine turns fatal or reports an adverse drug reaction.

These two features will not just benefit the patients, but both informed consent and compensation for the clinical trial participants give them the option to even withdraw from a human study, Prof. SP Thyagarajan, Pro Vice Chancellor, Sri Ramachandra University, Chennai told Pharmabiz.

But Dr Krathish Bopanna, president & executive director, Semler Research Centre, begs to differ and stated that the move on compensation is a threat to the clinical  research companies and we need to challenge this aspect of the law. This is primarily because there is no basis on which the compensation could be based because there are two aspects to the issue on whether it could be the test or the reference drug. Patients in a double blinded study could receive a placebo drug. We need clear cut guidelines and self regulatory norms.

ICMR begins process for further research in the field of stem cell research and therapy

January 30, 2012, 0800 IST – Source : PharmaBizNews

Even as the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) has recently announced that only haematopoietic stem cell transplants for blood diseases and limbal stem cell transplants for corneal diseases can be performed as standard therapy outside of clinical trials in India, the Union health ministry has started the process for further research in the field of stem cell research and therapy.

The Indian Council of Medical Research (ICMR), part of the health ministry, has invited concept proposals from scientists and clinicians working at various recognized institutions, universities and medical colleges in the country for initiating some basic as well as translational studies in the field of stem cell.

The studies will be conducted in the field of basic research and translational research. Under the basic research, the study will focus on stem cell biology of human embryonic stem cells (hESC) and induced pluripotent stem cells (iPSC) – induction and maintenance of stemness, mechanism and regulation of development and differentiation during growth and development, etc.

Under the translational research, the focus will be on ?Developing well characterised GMP grade hESC and iPSC lines; Establishing well characterised lineage specific cell lines in Xenogenic free media and human use grade reagents; preclinical studies on safety and efficacy of stem cells/products derived from different sources in appropriate models; preclinical toxicological evaluation of stem cells derived from different sources; ?Identification of new markers for stem cells / cell lines/progenitor cells/lineage specific cells from different sources; development of tests for immunogenicity and tumourogenicity; development of techniques for traceability of the transplanted stem cells/progenitor cells – markers and imaging etc; application of stem cells for drug development; and ?use of stem cells for gene therapy.

Besides, ICMR will initiate phase I/II clinical trials on human participants for well justified indications and duly wetted and approved clinical protocols; and use of nanotechnology in tissue engineering.

The ICMR’s initiative in this regard is significant as though the stem cell research holds great promise for improving human health by control of degenerative disease and restoration of damage to organs by various injuries; at the same time it also raises several safety, ethical and social issues.

Illiterate women lured secretly by clinical trial firms in Andhra Pradesh

February 03, 2012, 0800 IST  – Source : Pharmabiz News

A 55-year old illiterate woman, Sabavath Chilkamma, who volunteered as a clinical trial subject from Bhavanikunta tanda of Wardhannapeta mandal in Warangal district of Andhra Pradesh, had lost her life due to multiple organ failure. The unknown clinical trial company had offered to pay her Rs. 10,000 for volunteering as their subject for the drug trial. According to sources, it is believed that 20 people from Bhavanikunta thanda of Wardhannapet mandal have volunteered for drug trials together with Chilkamma. All of the volunteers were offered a sum of Rs. 10,000 per each person by an unknown clinical trial company to participate in the drug trial. When contacted and asked how many companies in the district are carrying out clinical trials in the district, the district medical and health officer Dr P Sambasiva Rao told Pharmabiz that he has no records of the number of companies carrying out drug trials or of those enrolled for clinical trials in the district. He said, “The clinical trial companies work secretly and target poor illiterate people by luring them with money to undergo drug trials.” In spite of such incidents by the clinical trial companies, the government has taken no concrete action against any clinical trial organizations in the state, because of which these companies are not mending their ways to comply with ethics of clinical trials and taking illiterate poor women for their drug trials, said a source from the Lambada Hakkula Porata Samiti. Meanwhile, Telangana Tribals joint action committee has demanded stringent action against those responsible for the death of Sabavath Chilkamma. As a precautionary measure the district health administration is planning to conduct a health camp to find out any medical abnormality in the four tribal hamlets of Wardhannapet mandal to avoid any further deaths. It is believed that since restrictions on drug trials were relaxed in 2005, the clinical trial industry in India has grown hugely and today more than 150,000 people are involved in at least 1,600 clinical trials, by various firms in India on behalf of leading foreign pharma companies like AstraZeneca, Pfizer, Merck, etc. Though there are no available official records, some estimates suggest the clinical industry may be worth as much as above Rs. 1400 crore in India. Regulators have struggled to keep pace with the explosion. Between 2007 and 2010, at least 1,730 people have died in India while, or after, participating in such trials.