Indian active pharmaceutical ingredient (APIs) industry is now keen to increase their global market share. In this regard, the industry is already working to chalk out a road map to increase opportunities in the regulated regions, it is also viewing the potential of the emerging markets in Africa, Russia and Latin American regions.
Currently, India is ranked second after China in global markets. There is market but there is stiff competition in terms of pricing of APIs in antibiotics, hypertensives and anti malarial drugs that include cephalosporin, quinilones and sartans.
Although there has been some efforts of Indian regulators in preventing Chinese manufacturers from marketing APIs that are found not be manufactured at good manufactured practices (GMP) compliant facilities, the government of India needs to intervene in the bias attitude towards the drug registration fee for exports and imports, Anjan K Roy, president, Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) and managing director, RL Fine Chem told Pharmabiz .
There is an unrealistic registration fee levied on China amounting to a mere Rs.2,000 to market the drugs in India as against an exorbitant Rs.20,000 for an Indian API to be sold in China. This attitude indicates Indian government's discrimination towards the domestic API producers. The main concern is the need for government support in preventing the API suppliers from China to market the range of drugs which Indian companies have the expertise, he added.
If an API from India needs to be marketed in China, product registration and facility checks are carried out only by the regulatory body with no agent intervention. However in India it is the reverse and only a product registration is valid with not plant checks. The industry abhors the partiality meted out to API companies from China. The end result is the circulation of substandard drugs marketed, stated Roy.
There is need to tap more opportunities in the global markets. The industry is looking to provide competitive prices and engage in the production of niche APIs to remain aggressive in the market, stated Roy.
The key strengths of India in the space are inherent expertise in chemistry. In the last 3-4 years, the sector has been recognized for its research and development capabilities R&D centres. Over the years, there has been an increased focus on augmenting the research quality and manufacturing practice, in addition to Intellectual Property security. Indian companies are also known to have a high number of Drug Master Filings (DMFs), stated industry sources.
The scene so far according to the Bulk Drugs Manufacturers Association is that the APIs industry is estimated to be around Rs.32,000 crore to Rs.35,000 crore ($6.61 billion to $7.23 billion) of the total Rs.78000 crore ($16.12 billion) Indian pharma industry. Out of the total API business, between Rs.15,000 crore ($3.1 billion) and Rs.18,000 crore( $3.7 billion) is from exports.
The industry has maintained almost 10 to 15 per cent growth both in API and its exports business. The country has around 600 API manufacturing companies. The country has world's second largest API manufacturing industry after China. The leading API companies are Dr Reddy's Labs, Ranbaxy Laboratories Ltd, Aurobindo Pharma, Cadila Pharmaceuticals Ltd, Sun Pharmaceuticals Industries Ltd, Cipla Ltd, Dishman Pharmaceuticals & Chemicals Ltd, Divi's Laboratories Ltd, Hikal Ltd, Orchid Chemicals & Pharmaceuticals Ltd, Torrent Pharmaceuticals Ltd., Biocon, Micro Labs, Bal Pharma, Strides Arcolabs, Nandu Chemicals, Shilpa Medicare, Bayir Chemicals part of Bayir Group and Orchid Chemicals among others.