Indian pharmaceutical industry will be able to find huge opportunities in the global generic market with steady growth in the number of prescriptions for generic drugs in developed countries. What is needed is a well prepared strategy for maximum utilisation of this favourable trend, according to industry experts.

The speakers at a one day seminar on "Opportunities, Challenges and Trends in Generic Drugs "organised by Indian Drug Manufacturers Association (IDMA) said that the growing generic market in the developed countries calls for technically well equipped and quality-assured performance from the Indian pharmaceutical firms. The companies should also take the Intellectual Property related issues into consideration and may establish partnership with local firms to explore the regulated market, they said.

Speaking on the current opportunities, challenges and trends in the industry, Dr R B Smarta, managing director, Interlink Marketing Consultancy Pvt Ltd, observed that the Indian companies have a better future in generic business as it is able to provide quality research and manufacturing activities along with cost saving practices and technologies. "The diversity of product dosage forms, strengths, packaging and regulatory challenge across continents offers a competitive advantage for modern Indian companies," he said. However, the opportunities in new generic products are becoming highly complex as the value added products get a competitive edge in the market and the business shall migrate to strong R&D players in India.

The companies may also build up relationships with the overseas companies, to set up operations in those parts of the world with a firm local grip. The quality of products and services along with the technical expertise offered by Indian firms makes the country's industry a competitive edge against Chinese pharmaceutical industry, he added.

The Indian companies, particularly the small and medium players, should develop specifications from day one to comply the quality standards of the developed nations, including compliance of United States Pharmacopoeia (USP) and British Pharmacopoeia (BP) for generic products, suggested Dr Vishwanath B Malkar, head-regulatory, Reliance Pharmaceuticals. The process analytical technology is getting more important in the filings for regulatory approval processes by increasing accuracy on the documentation and filing process. The R&D activities would play a major role in the cost reduction efforts of companies in generic pharma sector even as the small companies are getting into NCE research alliance with big pharma in the current scenario, he added.

Speaking on the regulatory issues related to generic industry, S W Deshpande, director general, All India Drug Control Officers Confederation (AIDCOC) commented that there should be a link between the Intellectual Property (IP) regulatory and the drug regulatory mechanism to counter the emerging IP litigation trend. At present, the drug regulator issues the product license to all the new drugs whereas the patent office would have issued patent for the product to one particular company. "As you know, some of such approvals has resulted in controversy and litigation, of late. The drug regulator should insist prior checking on patent of related products with the patent office before signing product approval," averred Deshpande.

The IP scenario and the trends are currently in a change mode in relation to the recent global developments, informed Gopakumar G Nair, CEO, Gopakumar Nair Associates, the patent consultant firm focusing on pharma industry. He said that the early litigation mode has switched over to a litigation settlement mode, where both the innovator and the generic company could share the market advantage through signing deals on authorised generics. The generic companies should explore the IP related filings and claims of the innovator company and identify the weak patent, niche molecules or products under weak patent and the niche market where patent laws have less strength for product development, he added. "The timing of patent challenges, proper networking with other generic companies for discussion, litigation costs and the chances for out of court settlements should also be considered by the generic company prior to entering into market with a new generic product," he advised the IDMA members.

Dr Shirish Kulkarni, director, Innovation Cell, Lupin Research Park, Pune, elaborated the opportunities in introducing value added generic versions, named as 'super generics'. He also suggested a few drug delivery methods, which could make the generic product much attractive than the innovator product, to build a market for the particular product.

Megha Dhargalkar, vice president - marketing and sales, Reliance Life Sciences described the emerging trends in the bio-pharmaceutical market of India and the opportunities ahead. The current trends of generic drugs in the retail pharmacy market was explained by Dr H P Tipnis, director, Pharmacy practice, Medicine Shoppe, in the meeting. Dr Tipnis said that the pharmacies should educate the people and doctors to promote generic products, which are cheaper and affordable to the patient population. He also added that there should be legal endorsement for pharmacist to get authorised to suggest and substitute cheaper generics to consumers.

B N Singh, president, IDMA, in his welcome address emphasised the need of Indian pharmaceutical companies to get updated on the generic trends, opportunities and challenges in the global pharma market.