Indian pharma companies are a step ahead of Schedule M and WHO GMP compliance, as they have succeeded in setting up manufacturing facilities that are approved by US Food and Drug Administration (FDA), UK MHRA, TGA Australia, MCC-South Africa, Health Canada and Invima Colombia. Companies have spent between Rs 20 lakh and Rs 5 crore for expanding facilities and building units to meet global regulatory requirements.
This growth of the Indian pharma industry can be attributed to its ability to rapidly conceptualize, execute and commission new infrastructure in line with international regulations, apart from its ability to capitalize on the market opportunity and meet future demand for multi product development. Also, its technically qualified and skilled work force has helped the domestic companies to comply with global standards.
There are as many as 74 US FDA approved drug manufacturing facilities in India - the highest outside US. Indian firms now account for 35 per cent of Drug Master File applications and one in four of all Abbreviated New Drug Application (ANDA) filings submitted to the US FDA. Apart, the number of generic drug introductions by Indian companies in US is expected to increase to over 250 by 2008 from 93 in 2003,according to industry analysts.
Presently, the pharmaceutical producers in the country export to over 65 countries. However, US is the largest customer and the biggest pharmaceutical market in the world, where the demand for generics is huge.
According to the KPMG report, the world pharmaceutical market is estimated to represent a $48 billion opportunity for India in 2007. The business will come from manufacturing or outsourcing supplies of active pharmaceutical ingredients (APIs) and intermediates, development outsourcing, conducting preclinical and clinical trials, customized chemistry services and contract research services for compounds.
According to Frost & Sullivan, global revenue from contract manufacturing and research services (CRAMS) is expected to touch $168 billion by 2009. Therefore, the contract manufacturing of ethically promoted drugs is expected to increase $43.9 billion. Significant growth is also expected from over-the-counter drugs and nutritional products. Both India and China account for 40 per cent of the outsourced market share for APIs, finished dosage formulations and intermediates.
"Indian pharma-biotech manufacturers can benefit from the outsourcing boom. There are many top-selling drugs going off patent. The country's patent regime has increased the confidence of the international companies. Domestic companies can now prove their mettle as the world's leading suppliers of affordable essential drugs with its plants compliant to stringent international quality standards," said, Ms. Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited.
Between 2006 and 2007, there has been a spate of acquisitions and mergers by Indian companies to take advantage of the global facilities with international regulatory compliance and for faster access to regulated markets.
Earlier this year, Jubilant Organosys, which has the largest CRAMS business in India, acquired all stakes of the US-based Target Research Associates, in addition to a 64 per cent stake in Trinity Laboratories and its wholly owned subsidiary Trigen Labs.
In another move, the Pune-based Bilcare Ltd, the pharma packaging major, acquired Philadelphia-based proClinical Inc - its first manufacturing facility in the US last year.
Strides Arcolab, one of the India's largest exporters of branded generic pharmaceuticals, acquired Diaspa's US FDA approved fermentation facility in Italy. It also acquired Farma Plus, Norway. In 2006, Strides signed a share purchase agreement with Haw Par Healthcare Limited, Singapore, for the acquisition of Drug Houses of Australia (Asia) Private Limited, Singapore [DHA]. The company's plants at Bilekahalli (for sterile injectables) and Jigani in Bangalore have received US FDA approval. In total, Strides has three US FDA approved units.
Kemwell India, a dedicated contract manufacturer, acquired the Pfizer unit at Uppsala in Sweden and is scouting for more acquisitions to attract orders from regulated market customers. The company is on the look out for mid cap pharma facilities in the US, South America and Europe to have a multi global presence. Its fourth facility at Neelamangala in Bangalore is built according to US FDA and EMEA requirements.
The Bangalore-based Micro Labs has bagged approvals from US FDA, MCC-South Africa, Health Canada and Invima Colombia for its 9 facilities, while Medreich Sterilab has four plants in Bangalore that are certified by the UK MHRA, TGA Australia and South Africa MCC. Micro Labs has four units in Bangalore and one unit each at Kumbalgod, Hosur, Goa, Pondicherry and Baddi.
On its part, Biocon also has a US FDA approved facility at the Biocon Park, which is declared as a Special Economic Zone. It is located at Bommasandra in Bangalore.
There has also been an effort by a small manufacturer in Karnataka, Srushti Pharmaceuticals, to set-up a unit of UK MHRA standards.
Specific to Karnataka, there are 115 units in the state that are all Schedule M compliant. The facilities that have the WHO GMP certification are AstraZeneca, Anglo French, Micro Labs, Strides Arcolab, Banner Pharma, Biocon and Medreich Sterilabs.
According Jatish N Seth, secretary, Karnataka Drugs and Pharmaceutical Manufacturers' Association and director, Srushti Pharmaceuticals, out of the 115 pharmaceutical units in Karnataka, at least 60 per cent have gone in for expansion and upgradation to grab a share of the global market opportunities.