With India being a signatory to WTO and the IPR (Intellectual Property Rights) regime coming into force in January 2005, the Indian pharmaceutical industry was faced with a lot of challenges and opportunities. The industry should act and react pro-actively to successfully face the challenges and take advantage of the benefits offered by the opportunities. In order to exploit the opportunities that would emerge in the IPR-driven markets, the Indian pharmaceutical industry should adopt international pharmacopeial standards, according to Ashwini Kumar, the Drugs Controller-General of India.

He was addressing a large gathering of the pharma industry, regulatory agencies and academia at the inauguration of a two-day international conference on Pharmacopeial Standards organised by the Bulk Drug Manufacturers Association (BDMA) in association with the Drugs Controller-General of India (DCGI), Indian Drug Manufacturers Association (IDMA), Indian Pharmaceutical Alliance (IPA), Organisation of Pharmaceutical Products of India (OPPI), Indian Pharmacopeia (IP), and the United States Pharmacopeia (USP).

Ashwini Kumar exhorted the industry to quickly implement the regulatory approaches adopted at the International Conference on Harmonisation (ICH) and the Pharmacopeial Discussion Group. He said it was imperative for the industry not only to keep abreast of the latest developments, but also to make changes and innovations as per international norms. India, he said, had been recognised the world over, including the developed countries, for its active pharmaceutical ingredients (APIs). "This is the soul of a drug which is used in the pharmaceutical industry. But still we should improve further by quality control," he said.

Ashwini Kumar said DCGI was trying to conduct a number of programmes in association with WHO to get a better understanding of the needs of the industry. He said Hyderabad was being hailed as the bulk drug capital of India. It had put India in the world map by maintaining high standards and making available drugs at affordable prices.

Delivering the inaugural address, K Vidydhar Rao, Major Industries Minister who is also the Vice-Chairman of the Task Force on the Pharma Industry in the State, asked the industry to invest aggressively in R&D for new drug discoveries. Quoting the McKinsey Report, he said the Indian pharmaceutical industry was poised to grow from the present $5 billion to $25 billion by the year 2010. To achieve this growth target, the industry should step up the export of generic drugs to the regulated markets, besides adding more therapeutic areas for domestic growth. Dismissing the apprehension among some Indian companies that the developed countries did not promote free entry of Indian products in the pretext of quality standards, the Minister said this could be overcome by setting up global standards for the products.

Roger L Williams, Vice-President and CEO of US Pharmacopeia, complimented the Indian pharma industry for the success it has achieved in the global markets. He said USP and the Indian pharma industry could work together to their mutual benefits. USP strongly supported good quality pharmaceuticals and harmonisation efforts that would allow all manufacturers to meet the same science-based pharmacopeial and other standards, he said.

Venkat Jasti, President of BDMA, stressed the need for evolving a uniform quality standard which would be applicable throughout the world. He said the conference would generate an understanding and awareness of scientific and technical issues related to specification of bulk pharmaceuticals, including non-complex and complex active and inactive ingredients.

The two-day conference is being attended by about 250 delegates form all over the country, the US, Canada, Bangladesh, Mauritius, Sri Lanka and Thailand.

The speakers at the plenary session touched upon specific topics such as universal tests, impurities, new monograph development, validation of analytical procedures and system suitability tests.

Eric B Sheinin, Vice-President, Information and Standards Development, USP, in his presentation on Compendial Monographs for Bulk Pharmaceuticals, said, "The USP promotes public health by establishing and disseminating officially recognised standards of quality and authoritative information for the use of medicines and healthcare technologies by health professionals, patients and consumers." According to him, a drug or device shall be deemed to be adulterated if it purports to be or is represented as a drug the name of which is recognised in an official compendium, and its strength differs from, or its quality or purity falls below the standards set forth in such compendium (section 501(b) of the Federal Food, Drug and Cosmetic Act). His presentation covered what should be included in a USP Monograph, how should impurities be limited, what are the appropriate limits, how to account for differing impurity profiles and when should work start on a new monograph.

Dr Judy Boehlert, Director, Boehlert Associates Inc, New Jersey, USA, in her presentation on New Monograph Development -Procedures, timeframe and reference standards, covered the USP guidelines to help the monograph preparation such as packaging and storage, reference standards and specifications. Included under the specifications are identification tests, tests for impurities, and assay, the timing of submission of a new monograph -3-5 years prior to the availability of a generic product. USP provides incentives for early submission of monographs.

Dr T G Chandrasekhar, Director and Head of Analytical Studies, Ranbaxy Research Laboratories, Gurgaon, in his presentation " Incorporation of Validated Methods for Pharmacopeial Submission to USP" said, validated methods were required to be incorporated in the pharmacopeials with respect to incomplete monographs, methods under review in PF, available method in USP, monograph not suitable or no monograph available. He also explained Ranbaxy''''s experiences with the USP - cases of Ranbaxy''''s recommendations which had been accepted and also changes made in the monographs. He wanted India to have a better collaboration with USP.

Dr Louis Coutinho, General Manager, Indian Operations, NuGenesis Technologies, spoke on impurities in drug substances and products. Quoting USP 25, he said, "Concepts about impurities change with time and are inseparable from developments in analytical chemistry. If a material previously considered be pure can be resolved into more than one component, that material can be redefined in new terms of purity and impurity. Inorganic, organic, biochemical, isomeric or polymeric components can all be considered impurities.

Dr Janos Pogany, Consultant to WHO Essential Drugs and Medium Programme, Budapest, Hungary, explained the world standards and the minimum requirements of pharmaceutical quality. De said the national guidelines and WHO guidelines might differ, but the same standards should be applied to imported and locally manufactured products.