DoP to organise a one-day 'National Convention on Biopharma' on July 12 in New Delhi

Considering the fact that India is a significant player in the global biopharmaceutical industry, the Department of Pharmaceuticals (DoP) is organizing a one-day 'National Convention on Biopharma' with participation from Department of Biotechnology (DBT) in partnership with Federation of Indian Chambers of Commerce and Industry (FICCI) with the support of Association of Biotechnology Led Enterprises (ABLE) on July 12, 2010, at FICCI House in New Delhi.

The objective of the convention is to bring stakeholders and the government together to discuss where industry needs facilitation and the support of the government to bridge the gaps for making the Indian biopharmaceutical industry live up to its identified and acknowledged potential of a leader. The convention will have speakers from academia, industry and government to share their experience and highlight issues.

The convention is significant as India is gaining momentum in positioning itself as significant player in the global biopharmaceutical industry. Presently, biotechnology drug candidates account for over 30 per cent of all pipeline research programmes. To achieve a leadership position in the global market, Indian biopharmaceutical industry and the government need to join hands to identify and address key issues and challenges. Despite the fact the Indian potential in biopharma has been well recognized across the world, the industry continues to struggle with issues like inadequate infrastructure and shortage of suitably trained and skilled manpower.

India is among the top 12 global biotech hot spots and the third largest in Asia Pacific (in terms of number of biotech companies). However the industry continues to struggle with issues like inadequate infrastructure and shortage of critical manpower.

This convention is to initiate a stakeholder consultation to discuss collaborative approach towards making the Indian biopharmaceutical industry globally competitive and sustainable and serving national need for quality healthcare for all.

Biopharmaceutical product development is characterized by high uncertainty of product outcome and a heavy reliance on R&D. Soaring time and cost of development is a serious challenge. Evolving technology requires regulations to be flexible and adaptive. All these issues along with a focus on infrastructure and HR gaps that need to be bridged for increasing the production in India will be discussed in the one-day convention.

This convention will also see a discussion on a biopharma strategy paper being prepared for DoP by ABLE and PwC.

Industry division of IPA plans to conduct a panel discussion on how to handle expired drugs

In the wake of the present expired drugs scam that plagued the entire pharma industry in Tamil Nadu, the Industry Division of the Indian Pharmaceutical Association plans to conduct a Panel Discussion on ‘How to Handle the Expired Drugs’. The programme will be conducted in Chennai.

Apart from experts in the industry, the discussion will be attended by senior officials from the departments of drugs control and pollution control board from southern states of the country, said J Jayaseelan, secretary of the Industrial Division, IPA.

Jayaseelan was elected to the post of Secretary to Industry Division in the national executive. Dr Kaushik Desai is the new president of the Division.

“We want to educate the public as well as the people in the industry and the trade. Even the manufacturers are not fully aware of the latest technology emerging in the industry. There are so many ways to handle the expired drugs. The recent issue has maligned the dignity of the industry and we are trying it not to recur. The manufacturers and the management of the industrial firms have to be trained and updated with the latest developments happening in the technology,” Jayaseelan said.

Prior to the experts’ discussion, there will be a symposium on the same subject where in representatives from Parma industries, wholesale distributors, retailers, faculties from pharmacy colleges and regulatory staffs will participate.

Since the subject has relevance at present, the participants can suggest ways and measures on how to handle the technology in the industry and how to recall the date expired drugs from circulation for destruction. Further to this, IPA will conduct training classes for people engaged in the drug business about the various methods of handling drugs and destruction of the date expired.

According to Jayaseelan, the secondary aim of conducting the symposium and the upcoming training classes is to educate the small and medium scale manufacturers.

In Tamil Nadu more than 400 SME units are functioning, but they are unable to train themselves or their staffs on the various methods of technology, not only for destruction purposes, but also for development of new drugs. So these initiatives of the IPA will help them attain knowledge based resources to benefit their business also. IPA will start such programs in other states too shortly, he said.

US FDA to set up the site inspections of clinical trials in the developing countries

Under increased pressure from the Department of Health and Human Services, the US Food and Drug Administration (FDA) which has already set up representative offices in many countries including India, may soon step up the site inspections of clinical trials in the developing countries.

Based on a recent report on the oversight of foreign clinical trial data, the health department has already called upon the FDA to improve the inspections. Though India was not specifically mentioned as a key destination, being one of the most favourite sites for trials for the vast number of subjects and other factors, the drive may cover India largely also, according to the information reaching here.

The report had found flaws in FDA oversight of foreign clinical trials as the sponsors were found to be relying heavily on the data generated from abroad to support their marketing applications back home. While 80 per cent of drugs and biologics applications approved by the FDA in fiscal year 2008 contained clinical trial data from foreign sites, the agency inspected clinical trial investigators at only 0.7 per cent of foreign sites compared to 1.9 per cent of domestic of domestic clinical trial sites, revealed a report by the HHS’s Office of Inspector General.

Over the years, India has been emerging as a key destination for trials by the companies from the developed world. Though the exact number of trials by the US companies in India is not known, a search in the official Clinical Trial Registry of India (CTRI) has found that there are hundreds of trials going on in the country with the sponsors from the US. The FDA is likely to make use of its manpower at the two representative offices in Delhi and Mumbai for the purpose of on-site inspections of trials as it was one of the key agenda while setting up the offices here.

According to the HHS report based on the figures of 2008, Western Europe account for 58 per cent of subjects enrolled at foreign sites and 60 per cent of foreign sites. Central and South America also enrolled a significant number of subjects – around 26 per cent of all subjects at foreign sites – but the region accounted for only 7 per cent of total foreign sites. Peru, the report notes, had the fourth-largest subject enrolment, yet the FDA inspected no trials there. The report also lists several other countries with a large number of subject enrolments that were not inspected by the FDA for marketing applications approved in FY 2008. These include: Colombia, Chile, Panama, Venezuela, Nicaragua, the Dominican Republic, Denmark, Norway and Poland.

The domestic industry sources said India in fact gained more attention as a favourite destination in the recent years. Large number of trials by the US companies started here only after 2008 and hence India was not specifically mentioned in the report. The situation has changed a lot now and there could be added pressure on the investigators for the better, if the FDA steps up the inspections.

Growing generic opportunities of Indian Pharmaceutical Industry

Indian Pharmaceutical industry ranks third worldwide by volume of production and 14th by value there by accounting 10% of world`s production by volume and 1.5% by value. The total turnover of Pharma industry was at Rs 1,0061.11 billion for the year ended September 2009, where domestic pharma market contributes about 58% or Rs 586.26 billion and exports contributes 42% or Rs 419.85 billion.

Pharmaceutical Industry in India is one of the largest and most advanced among the developing countries. Indian pharmaceutical industry has progressed tremendously on infrastructure, technology development and a wide range of products over past two decades. As Indian companies can deliver good quality of drug with lower cost, it now preferred destination for most of advanced countries. Most Indian companies maintain highest standards in purity, stability and international safety health and environmental protection in the production and supply bulk drugs to even innovator companies.

Broadly Indian Pharmaceuticals sector is classified into Bulk drugs, Formulation and Contract Research and Manufacturing Services (CRAMS). The drug and pharmaceuticals industry in India meets around 70% of the country`s demand for bulk drugs, drug intermediates and formulations. There are about 500 corporate players with more than 20000 players in general and thus fragmented Indian pharmaceutical industry. The bulk drugs and pharmaceuticals manufacturers produce complete range of pharmaceutical formulation and about 350 bulk drugs.

In the last two years, the patent of drugs wroth of USD 40 billion has expired. The value is set to double (USD 83 billion) in the next three years. This gives ample opportunity to Indian companies. At the same, India is also become favorable destination for CRAMS business. India can develop a drug at half cost compared to advanced countries and can manufacturing drugs at 30-40% of production cost of advanced countries. M & A in Indian Pharmaceutical industry revived started with Japanese major Daichii Sankyo acquiring majority stake in India`s pharma leader Ranbaxy Laboratories, then followed by Sanofi-Aventis acquiring 80% stake in unlisted Shantha Biotechics and Hospira acquiring Orchid Chemicals & Pharmaceuticals` generic injectable business.

``Globally, pharmaceutical industry is witnessing M & A due to attractive valuation. But in the case of India, there are more buyers than seller, but the former feel that the current valuations are higher. As a result, frontline players are keener on acquiring brands rather than acquiring companies. On an overall basis, the growing global generic markets, increasing CRAMS opportunities and strong growth in domestic market are the key drivers of Indian Pharmaceutical industry. ``

FDA and NIH launched a new website for reporting pre- and post-marketing safety data

The Food and Drug Administration and the National Institutes of Health on 24th Of May 2010 launched a new Web site that, when fully developed, will provide a mechanism for the reporting of pre- and post-market safety data to the federal government. Currently the Web site can be used to report safety problems related to foods, including animal feed, and animal drugs, as well as adverse events occurring on human gene transfer trials. Consumers can also use the site to report problems with pet foods and pet treats.

The new site, called the Safety Reporting Portal (SRP), provides greater and easier access to online reporting.

“The portal will be a key detection tool in improving the country’s nationwide surveillance system and will strengthen our ability to protect the nation’s health,” said Commissioner of Food and Drugs Margaret A. Hamburg. “We will now be able to analyze human and animal safety-related events more quickly and identify those measures needed to protect the public.”

The new Web portal includes different features for different types of reporting:

• Reportable Food Registry: Industry will have a more user-friendly electronic portal for submitting reportable food reports that are required by law. This electronic portal collects reports from the food industry and public health officials regarding problems with articles of food, including animal feed, that present a reasonable probability of causing serious adverse health consequences or death to humans or animals.

• Pets: Pet owners and veterinarians will be able to use the portal to report product problems with pet foods and pet treats.

• Animal drugs: Animal drug manufacturers can report adverse drug events associated with animal drugs.

• Clinical Trials: Biomedical researchers involved in human gene transfer clinical trials can report an adverse event, indicating whether it might be an unanticipated consequence of the product being tested. Trial sponsors can use the portal to prepare a report, print it and send it to the agency to satisfy reporting requirements for investigational new drugs.

In the future, the system will encompass other types of clinical trials and, eventually, safety problems arising from products regulated by a broad array of federal agencies. This is a first step toward a common electronic reporting system that will offer one-stop shopping, allowing an individual to file a single report to multiple agencies that may have an interest in the event.

Just as important, the portal will ultimately enhance the government’s systematic analysis of safety information, which will benefit public health. In the meantime, the new portal redirects individuals who want to submit reports about other products regulated by FDA, the U.S. Department of Agriculture, Environmental Protection Agency or the Consumer Product Safety Commission to the appropriate contact.