The global pharmaceuticals market for generics or drugs that have gone off patent is around US$ 40 Billion and the process development skills and low -cost manufacturing has made Indian Pharma a Dollar 6 Billion industry.
Pharmaceutical industry in India is one of the largest and most advanced among developing countries. The Indian pharmaceutical industry not only manufactures bulk drugs belonging to several major therapeutic groups requiring skilled manufacturing process but has also developed excellent facilities for production of all dosage forms like tablets, capsules, liquid, orals and injectables. Today, Indian pharmaceutical industry produces a complete range of formulation and meets nearly 75 per cent of the country's requirement of bulk drugs.
The Indian pharmaceutical industry is maintain highest standards in purity, stability and international requirements of safety, health and environmental protection in production and are also having well equipped R & D laboratories and modern pilot plant facilities alongwith adequate human resources which are essential for a new drug molecules, clinical research and new drug delivery systems. The expenditure of R & D facilities is increasing every year.
The commitment of the industry toward research has ensured that Indian pharma products are of excellent quality and very competitive pricing. More and More Indian companies are now seeking regulatory approvals in USA in specialized segments like antiinfectives, cardiovasculars, central nervous system stimulants (CNS group). Along with Brazil and Pr China, India has carved a niche for itself by being a top generic pharma player. An indicative cost comparison, in the present context, that medicines available in developing countries are 2.7 times costlier compared to Indian prices and in developed countries like USA, UK, Europe, South Africa and Australia are 50 times more costlier then Indian medicines prices.
This is where; a greater emphasis has to be laid down to having a two-way strategy, one for the developing world and the other one for the developed world. For the developing world like South Asian Region, Africa, Latin America and CIS countries, the emphasis should be to produced and market medicines in volume at affordable prices. In these countries, there already exists primary manufacturing facilities meeting from 10% to 30% of the requirement of people for medicines in those countries their requirement is mainly for generic and off patent medicines and their requirement can only be met from developing countries, which have a well established pharmaceutical industries due to stringent regulatory systems and infrastructure for manufacture, distribution and are responsible for safety, efficacy and quality of drugs.
India's exports of drugs & pharmaceuticals are mainly through Mumbai, Chennai and Delhi and are growing @ 19.8% per annum and today stands at around Rs. 16,000/- crores and with the base of approximately 6,000/- manufacturers.
In 2003 - 2004, regulatory authorities lifted 38,000 samples of medicines for quality testing and only 0.33% of it was found to be below standards. In the same period 2578 samples of imported drugs were tested and 254 samples, nearly 10% were found not to be of standard quality and 6 samples were reported to be spurious quality. This shows India's capability in producing quality medicines at much lesser costs. In the current year, it is targeted that around 100,000/- samples of medicines would be lifted.
In the developed countries, exports can go up, if we upgrade our manufacturing facilities to world class standards such as USFDA, UKMCA, TGA of Australia MCC South Africa and ICH. The emphasis on these stringent regulatory requirements are aimed to reduce impurities to the barest minimum levels by controlling cross contamination and proper checks during manufacturer of medicines. There are around 65 USFDA approved facilities at the moment and are growing at much faster rate in the direction of obtaining USFDA approvals.
R & D is an essential requirement and spending is critical, though success depends largely on opportunities available. Indian pharma companies are increasing their investment from 7% of their turn over to around 18% spent by multinationals pharma giants. The Indian giants will have to focus on innovations, creating intellectual property, global presence in key markets and build up a strong and sustainable R & D base.
With the cheap labour force and high skills, the sub continent can become a hub for reliable, cost effective medicines supplier to the world. In developed countries, we should take advantage of the cost factor and in the developing countries; we can meet their requirement of medicines at affordable prices and unmatched quality. We should make joint efforts for the following:
1. Press our governments to shorten the transaction costs by opening land borders for movement of goods from Wagha, and other borders.
2. Have joint cooperation in offering training, of skilled labour and officers required to maintain highest standards of production on good manufacturing practice There can be a exchange of students, drug inspectors, scientist, lawyers, industry and consumer associations for training.
3. Develop a SARRAC pharmacopoeia to cover standards required in the sub continent.
4. To built a buffer stock of emergency stock of essential drugs of both generic and proprietary drugs to deal with any unforeseen calamity in the sub continent and to foreign country in Africa.
5. To start cultivation, standardization of herbal drugs in form of neutraceuticals, cosmetic, chemical standardized herbal drugs, unani system of medicines. There is an urgent need of comprehensive, co-ordinated, socio-economic research and documentation on international scale.
6. To make joints strategy to capture a larger share of off patent drugs in 2008.
7. To jointly focus on market tie-ups.
8. To forge strategic relation for exclusivity rights or contract research and manufacturing.
9. To tap fresh export market in developing countries.
10. To have joint stand for WTO issues.
Click here to view table showing exports to top 15 countries
- (The author is Chairman, Pharma Panel, Chemexcil)