Pharma industry - Opportunity post 2005

There’s no doubt about the future of Indian pharmaceutical industry which is mature enough to face the challenges and grab the opportunities by interacting with the global industry and taking advantage of the facilities, manpower and the information technology base of the country, says Dr M Venkateswarlu

THERE is an apprehension in the minds of people connected to the pharmaceutical industry about what will happen to it after 2005. The World Trade Organisation (WTO) may restrict some of the reverse engineering activities, which is being followed by Indian pharmaceutical Industry for the last three decades. But it will open up a large number of opportunities as India slowly and steadily gets recognised by the global pharmaceutical industry for outsourcing their activities.

As such the current value of drug production in this country is about Rs 22,000 crore, out of which a marginal Rs 2000 crore to Rs 3000 crore belong to sale of drugs covered under patents. The remaining Rs 18,000-20,000 crore sales are from drugs which are not under patents. So, Indian pharmaceutical industry can continue to manufacture off patent drugs with an annual growth rate of 10 per cent.

In addition, there are large number of molecules coming off patent by 2005. It will also add to the volumes of drug products marketed as well as exported from this country. The opportunities for 2005 lie in the following activities areas.

i. Contractual research
ii. Nutraceuticals
iii. Cultivation of medicinal plants
iv. Discovery research & New Drug Delivery System.

The Indian pharmaceutical industry has already recognised the need to create the state-of-the-art facilities with the latest equipment and automation to meet global regulatory requirements. There must have been at least 60 such facilities created in the last five years and all of them are expecting to make their presence felt in the regulated markets through registration procedures and maintaining high standards of Good Manufacturing Practices (GMP).

They are also parallely trying to build up the local base by introducing new molecule, and new dosage forms.

The established Indian large scale manufacturers are growing locally and in exports thereby the facilities created by them. They are looking forward to get the work done by some of the small manufacturers complying to national GMP requirements. So this chain reaction of the established Indian large scale manufacturers trying to cater to the global needs and developing the small scale industry to meet their local demands is going to create huge opportunities for the Indian pharmaceutical industry, both large and small scale.

India has become self-sufficient in majority of the equipment required for the manufacture, maintenance and utilities. They also develop the skills to create the state-of-the-art facilities in a very short period. The Indian pharma industry is totally aware of the global GMP requirements, which they started practising in their factory and as on date there are about 250 manufacturing units, which are, recognised by international agencies and bodies.

This includes manufacturers of APIs by chemical synthesis, manufacturers of bulk substances by biotechnology, manufacturers of various dosage forms such as tablets, liquids, injectable, and aerosols.

Contract research

India has an excellent strength in their manpower, the large pool of scientists from basic sciences as well as applied sciences. This includes post graduates and doctorates. This talent is being utilised by Contract Research Organisations (CRO’s). The global pharmaceutical industry is looking to outsource some of their research activities.

This global trend is creating ample opportunity by India CRO’s to grab these opportunities that are available to them in formulation development customer synthesis, clinical data management, clinical trial, BE/ BA studies, packaging development studies etc.

There is also an ample opportunity for CRO’s to develop dossiers of Abbreviated New Drug Application (ANDA) and create facilities for the manufacture of clinical trials batches. It’s high time when pharmaceutical industry looks into the opportunities available to them to be a CRO for activities around biotech and biological products.

Nutraceuticals

Nutraceuticals have a global mark of U $86 billion dollars and the herbal products can take substantial share in the nutraceutical markets. India has knowledge about herbs through the ayurveda, which is very ancient. What is required is to modernise the ayurveda to meet the current global GMP requirements. If we are able to establish the quality parameters of nutraceuticals to match the global requirements there are tremendous opportunities to take a share in the global market.

Cultivation of medicinal plants

India is an agro-based country. There is enough scope for developing cultivation of medicinal plants and the cultivation through co-operative sectors on scientific basis as there is large demand for medicinal plants in the global herbal pharmaceutical/ nutraceutical industry.

India also has varying climates within the country to meet the specific requirements of different medicinal plants. It also has a large coast line but not much has been done to develop marine products for pharmaceutical use.

A focussed approach to carry out the research on marine products for pharmaceutical use will certainly give opportunity to the country to produce pharmaceutical products from marine resources for local use as well as exports.

Discovery research & New Drug Delivery System

Indian pharmaceutical industry has already initiated efforts in New Drug Discovery. Some of the major players like Ranbaxy, Reddy’s Laboratories, all are on the verge of bringing new chemical entities. In course of this discovery research they are collaborating with other established research laboratories of the world.

As the discovery research is very expensive and time consuming, some of the manufacturers are focusing New Drug Delivery System to improve the efficacy and convenience of drug administration. So, post 2005, this activity is going to pick up as they also get the benefit of patent protection.

The pharmaceutical industry post 2005 is all set to grow at their annual growth rate of 10-15 per cent in the local market and a substantial growth in exports. The signing of WTO will give confidence to the multinationals to identify India as one of the major centres for outsourcing all their activities connected to drug development, drug manufacture etc.

I have no doubt about the future of Indian pharmaceutical industry which is mature enough to face the challenges and take the opportunities by interacting with the global industry and taking advantage of the facilities, manpower and the information technology base of India.

Dr M Venkateswarlu is Dy. Drugs Controller (India), CDSCO West Zone Mumbai e-mail: cdsco@vsnl.net