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Pharma major Cipla plans to invest Rs 500 crore for setting up an active pharmaceutical ingredients (API) facilities at Patalganga, Bengaluru and Kurkumbh.
The setting up of these facilities is expected to be completed by 2012-13, the company said in its annual report.
The report said that several dosage forms and APIs manufactured at the company’s facilities continued to enjoy the approval of major international regulatory agencies such as USFDA and WHO.
The company is actively involved in developing bio- similars/ bio-therapeutic products through its partners in China.
It is expected that the clinical trials on these drugs will be completed in 2-3 years and subsequently, the products will be launched in India.
The company’s venture into stem cell-based products is under progress with a major investment in Stempeutics Research Pvt Ltd, Bengaluru.
Currently, clinical trials for regulatory approvals for certain therapeutic areas are underway in India and Malaysia.
The launch of the stem-cell-based products is expected in three years, it said.
The company said international business also continued to be a major revenue driver.
During FY2011-12, more than 53 per cent of the total income originated from international markets.
The company is expanding its presence in the inhaler segment in Europe, with regulatory approvals for a few products already in place and few more in the pipeline. In the US, the company is exploring all options, including filing its own Abbreviated New Drug Applications (ANDAs), it said.
On drug pricing, the company said there is a lot of uncertainty on the New Drug Policy, which is likely to be based on the “NLEM” - National List of Essential Medicines.
The policy seeks to impose a drug price control regime on more than 348 drugs on the basis of essentiality.
India is known as the pharmacy capital of the world not only for its quality and range but also for its prices as well.
India enjoys the lowest prices of medicines in the world - cheaper even than Bangladesh, Pakistan, Indonesia.
The government must move away from price control to price management and the earlier it does so, the better for the industry and consumers, it said.
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