India to Remain Top KPO Delivery Site

India will remain the top knowledge process outsourcing (KPO) global site despite challenges from China, the Philippines and Sri Lanka.

Ovum, an independent technology analyst company which released the report on Monday, said that the emergence of new KPO providers in the Asia-Pacific region gave companies that offshore their work more options to select from.

"Being able to delivery services from multiple locations means providers can offer existing clients greater flexibility and minimise the risks associated with having all their operations in one facility, while at the same time tapping into fresh labour pools," Ovum analyst Ed Thomas said.

The lower labour cost and English-speaking manpower in these nations have expanded offerings of KPO companies from the initial research and analytics to more services such as legal process and clinical trial management.

Read more...

Need to boost clinical tests: NARI Director

India needs to develop infrastructure and trained manpower to carry out clinical research on a large scale in view of its huge population and demand for increasing drugs and research studies.

This was stated by Dr Ramesh Paranjape, director of the National AIDS Research Institute (NARI) while inaugurating a seminar on clinical research at the Symbiosis Centre of Health Care (SCHC) on Friday. “We need to develop strength in clinical research and quality control which is not that effective at present,’’ he said.

Paranjape stressed on the importance of pre-clinical research and said, “It is one of the important elements of the trial, so that new molecules can be produced in the country. We need manpower and trained staff, for which training in clinical research courses should expand and institutes are advised to consider it.’’

The scientist pointed out that India has a large population susceptible to communicable and non-communicable diseases. “We should conduct clinical studies for growing requirement of drugs,’’ he said.

Read more...

India issues guidance on clinical trial inspections

India’s Central Drugs Standard Control Organization (CDSCO) has issued guidance for regulators and sponsors on clinical trial inspection procedures.

The document issued by CDSCO, part of the Directorate General of Health Services at India’s Ministry of Health and Family Welfare, sets out the objectives, scope and particulars of the government’s clinical trial inspection programme,

The inspection programme covers all sites and sponsor/contract research organisation (CRO) facilities involved in clinical studies of drugs, biologicals and medical devices regulated by India’s Drugs & Cosmetics Act.

The aims of the programme are to verify:                                            

• compliance with Good Clinical Practice, so that the rights, safety and well-being of clinical trial participants can be protected;
• The credibility and integrity of the data generated in clinical trials;    
• Compliance with various other regulatory provisions, as laid out in the Drugs & Cosmetics regulations.

The guidance will give direction to inspectors/CDSCO officers on inspecting clinical trial sites, sponsor/CRO facilities and information supplied to investigators, the Organization said. It will also guide sponsors/CROs on the procedures applied in inspections and follow-up actions.

Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections

The document spans a wide range of issues, from planning for inspections to delegation of responsibilities, study protocols and record retention at clinical trial sites; and monitoring of investigators, quality assurance and data collection by sponsors/CROs.

The guidance is in line with wider government efforts to tighten up the regulatory framework for clinical research in India. The rapid growth of the sector in recent years has prompted concerns about lax oversight of clinical trials and CROs.  

In July 2009, for example, the Drugs Controller General of India issued draft rules for the registration of clinical research organisations, while the previous month a new rule took effect under which all studies conducted in India had to be logged in the clinical trials registry set up by the Indian Council of Medical Research.

A programme of Good Clinical Practice (GCP) inspections and audits was launched in 2009. Earlier this year, there were press reports in India that trained inspectors from the Ministry of Health and Family Welfare would shortly be carrying out spot inspections of clinical trial sites to ensure compliance with GCP.

Source: Central Drugs Standard Control Organization

Read more...

Parliamentary panel finds 10 to 12 Indian pharma cos seriously into new drug discovery research

Clinical Trials in India

The Parliamentary Standing Committee on Chemicals and Fertilisers assessed that the research and development in the Indian pharma industry was picking up and at least 10 to 12 leading companies are into new drug discovery now.

Some of them have increased their R&D spending to four to 10 per cent of their turnover compared to the mere average of just 2 per cent earlier. The drug and pharmaceuticals industry as a whole has the potential to grow manifold and contribute significantly to the global drug requirements, particularly in the generic segment, according to the presentations made at a meeting of the panel.

The committee also took views of officials and stakeholders on the subject of ‘National Policy on Petrochemicals vis-a-vis Growth of Petrochemical Industries,’ apart from assessing the health of public sector and private sector pharma industries.

“It is gathered that a few products are expected to go for clinical trials in the next few years in the areas of anti-infective, anti-cancer and lifestyle segments. With the application of product patents in case of pharmaceuticals, the confidence levels of Western pharma companies towards India for contract R&D work is going up. While Indian companies by themselves are also conducting clinical trials in India, due to availability of upgraded infrastructural facilities, the country is becoming a hub for trials for the MNCs outside,” the panel was told.

The industry has witnessed a robust growth over the past few years moving from a turnover of about $1 billion in 1990 to over $20 billion in 2010 of which the export turnover is around $8 billion. The industry ranks third in terms of volume and 14th in terms of value. India has 22 per cent share in the 84 billion dollar world market of generics, according to the official figures presented before the panel.

“While the pharmaceuticals exports are growing at over 17 per cent over the last three years, the domestic market is showing a growth of 14 to 15 per cent during the same period. The domestic market has touched Rs.60,000 crore sale in 2010 from Rs.39,989 crore of 2006-07,” the statistics said. The panel also viewed that almost 60 billion dollar worth medicines are likely to come off patent in the next few years and India is poised to emerge as a significant player in the area.

The panel also discussed issues relating to the policy measures, the performance of PSU drug manufacturers, their revival plans, concerns of the private industry, the Schedule M constraints, patent issues, acquisition of Indian companies by multinationals etc. The committee also took inputs from the stakeholders represented through some associations.

Parliamentary Standing Committee, Chemicals and Fertilisers assessed that the research and development in the Indian pharma industry was picking up and at least 10 to 12 leading companies are into new drug discovery now.

Some of them have increased their R&D spending to four to 10 per cent of their turnover compared to the mere average of just 2 per cent earlier. The drug and pharmaceuticals industry as a whole has the potential to grow manifold and contribute significantly to the global drug requirements, particularly in the generic segment, according to the presentations made at a meeting of the panel.

The committee also took views of officials and stakeholders on the subject of ‘National Policy on Petrochemicals vis-a-vis Growth of Petrochemical Industries’, apart from assessing the health of public sector and private sector pharma industries.

“It is gathered that a few products are expected to go for clinical trials in the next few years in the areas of anti-infective, anti-cancer and lifestyle segments. With the application of product patents in case of pharmaceuticals, the confidence levels of Western pharma companies towards India for contract R & D work is going up. While Indian companies by themselves are also conducting clinical trials in India, due to availability of upgraded infrastructural facilities, the country is becoming a hub for trials for the MNCs outside,” the panel was told.

The industry has witnessed a robust growth over the past few years moving from a turnover of about $1 billion in 1990 to over $20 billion in 2010 of which the export turnover is around $8 billion. The industry ranks third in terms of volume and 14th in terms of value. India has 22 per cent share in the 84 billion dollar world market of generics, according to the official figures presented before the panel.

“While the pharmaceuticals exports are growing at over 17 per cent over the last three years, the domestic market is showing a growth of 14 to 15 per cent during the same period. The domestic market has touched Rs.60,000 crore sale in 2010 from Rs.39,989 crore of 2006-07,” the statistics said. The panel also viewed that almost 60 billion dollar worth medicines are likely to come off patent in the next few years and India is poised to emerge as a significant player in the area.

The panel also discussed issues relating to the policy measures, the performance of PSU drug manufacturers, their revival plans, concerns of the private industry, the Schedule M constraints, patent issues, acquisition of Indian companies by multinationals etc. The committee also took inputs from the stakeholders represented through some associations.

Read more...