DOORWAY TO PHARMA INDUSTRY IN INDIA
INTRODUCTION
The Indian Pharmaceutical industry currently tops the chart amongst India’s science based industries with wide ranging capabilities in the complex field of drug manufacture and technology. Amongst all the countries that fall under the category of developing countries, the Indian pharmaceutical industry is one of the biggest and the most advanced. It provides employment to a huge number of people and ensures that vital drugs are made available to the huge population of India at affordable rates.
The drugs and pharmaceutical industry plays a pivotal role in the economic development of India. Being a very intense knowledge-based industry, it offers innumerable business opportunities for investors worldwide.Indian pharmaceutical exports accounts for export to more than 200 countries around the world. The annual turnover of pharmaceutical products contributes to about US$ 17 billion. In recent times, the Indian pharmaceutical industry has shown tremendous growth in terms of infrastructure development, product usage, and technology.
As per the research Report by CII, March 2012, the organized pharmaceutical industry is estimated to be worth $ 4.5 Billion, growing at about 8 to 9 percent annually. It ranks very high amongst all third world countries, in terms of technology, quality, and the vast range of medicines manufactured. It ranges from simple headache pills to sophisticated antibiotics and complex cardiac compounds, almost every type of medicine is now made available in the Indian Pharma Industry.
The Indian Pharma Industry meets around 70% of country’s demand for bulk drugs, drug intermediaries, pharma formulations, chemicals, tablets, capsules, orals and injectibles. The Indian pharmaceutical market is expected to touch US$ 74 billion sales by 2020 from US$ 11 billion now, according to a PricewaterhouseCoopers (PwC) report. India's pharmaceutical market grew at 15.7 per cent during December 2011, with growth in key therapy areas, including anti-diabetics, derma and vitamins outperformed the market, according to data compiled by market research firm All India Organisation of Chemists and Druggists (AIOCD).
Pharmaceutical Industry is divided into four parts, i.e. Active Pharmaceutical Ingredients (APIs), Contract Research and manufacturing services (CRAMS), formulations and Biosimilars.
MARKET OVERVIEW AND TRENDS
- Research & Development
Indian Pharma Companies spends around 2 percent of their total turnover on R&D. And, it is really important for a Pharma Company to do Research on the drugs, the expenditure is likely to increase in the coming years due to the introduction of product patents
- Clinical Trials
Since India has cheap labor costs and low costs for manufacturing, we are becoming hub for clinical testing and experiments.
- Revenue from Exports
Now, with complete liberalized Pharma Sector and new domestic as well as International players, Indian Pharma Export Market is becoming progressive due to strong presence in the generic space
- JVs (Joint Ventures)
It has been witnessed that many Multinational Companies are now collaborating with Indian Pharma firms to take advantage of India and to develop new drugs
- Product Patents
With the entry of Indian Patents Act, the discovery of new drugs has been a boost to Indian Economy.
REGULATIONS FOR ENTERING INDIAN PHARMA INDUSTRY
- Drugs & Cosmetics Act, 1940 (for approvals required from Drug Controller General (India) DCGI regarding import, manufacturing, sale and distribution and conducting clinical trials)
- Drugs & Cosmetic Rules, 1945
- Indian Patents Act 1970 (for protecting the brand/ new discovery of drugs)
- Factories Act, 1948 (in relation to license for carrying out manufacturing activities)
- Environment Protection Act, 1986 (all the licenses related to environmental matters including disposal of biomedical wastes, etc and Registration from industrial departments, Pollution Control Board, Boilers Act, Explosive Department’s license)
The main regulatory body is the Central Drugs Standard Control Organization (CDSCO), which falls under the ambit of Ministry of Health and Family Welfare. Drug Controller General of India (DCGI) is the controlling body for CDSCO and is responsible for approval of new drugs and clinical trials and quality standards.
And, there are State Drug Authorities which grants drug licenses for manufacturing and licenses for retail/ Wholesale trading. Also, Government regulates the prices for essential drugs through National Pharmaceutical Pricing Authority (NPPA). The Prices for essentials drugs and medicines are defined under Drug Price Control Order (DPCO).
The Department of Pharmaceuticals which came into existence in 2008, works for the development of Pharma sector in India. It regulates the complex issues related to medicines that may be accessibility, availability of the medicines, Research & Development, and protection of IP Rights related to Pharma industry in India.
Achieving regulatory compliance is very essential for pharmaceutical companies. Non-compliance internationally can lead to large fines, product recalls or delays in product approval, reputational risks and plant shutdowns. Delays in statutory compliance with national, state and municipal level laws can lead to major monetary loss, imprisonment etc., in addition to unnecessary waste of time and energy. In India, statutory compliance varies from state to state.
Pharma companies (MNCs and Indian) are located across multiple countries/geographies and states within a country and are exposed to both national and international legalities.
Clinical Research Organizations (CROs) may have specific regulations like 21 CFR 11, HIPAA etc. applicable to it. At times at the R&D centre of pharma companies, laws like 'Petroleum Act' may apply other than The Drugs & Cosmetics Act and the Drugs & Cosmetics Rules.
FUTURE OUTLOOK
PHARMACETICALS
Pharma Sector in India is progressive in terms of infrastructure development, technology and number of medical products manufactured. And, the Indian Market has number of advantages such as growing population, rising income, cost effective drugs with world class laboratories.All of the drugs which have complicated manufacturing processes and those which belong to major therapeutic group are being produced in India.
Government in its objective to promote the pharma sector and to increase the exports have set up duty free zones. Because of which many of the manufacturers are shifting their focus to Active Pharmaceutical Ingredients (APIs). Moreover, the favorable regulatory environment increased the spending on Research & Development (R&D) and improved technical skills in the field of chemical synthesis have also played an important role.
CRAMS
Indian clinical trial market has been growing much more rapidly than that in the developed markets of the US and the EU, as well as other emerging economies.
According to Express Pharma Online, India is one of the preferred destinations for outsourcing clinical trials. The reason behind this is the low cost labor in India. The Indian Contract Manufacturing Industry is set to rise as innovator pharma companies continue cutting costs by outsourcing their manufacturing to India.
So, India is emerging as a low-cost, high quality option for outsourcing of research, manufacturing and other services.
“MEDICAL TOURISM”
The idea of foreigners flying overseas to get a heart valve replacement before sightseeing at the Taj Mahal is no longer foreign. In fact, medical tourism is an imminent business globally, and the people packing their bags most frequently are foreigners. Medical tourism is basically to serve as a broker between medical tourists, and medical service-providers worldwide. It also bridges the gap of language problem of patients who have come from different countries to India for low cost treatments.
The broker needs to open and design a web portal for this business to attract the tourists. Also, tie ups with leading hospitals and top travel agencies can also help in supporting the business.
The potential revenue stream from this business could involve facilitating travel arrangements, and taking a margin from travel agencies and associated hospitals. The portal would aim to become a part of the nip-tuck tourism, where travelers combine pleasure with procedures. So, why waiting, just start doing business. Global medical tourism is itself poised for growth, so start up can expect a good market, if promoted well.
