India 2013 Wrap-up

Over the course of 2013, India’s healthcare sector took several steps to strengthen drug and clinical trial regulations, re-established the elected Medical Council of India, and made progress in the Health Ministry’s work to develop alternative and cheaper technologies like an indigenous kit to test for cervical cancer.

However, other initiatives did not fare as well.  The proposal to start a new Urban Health Mission to give the urban poor quality healthcare did not receive adequate funds, while the initiative to provide universal healthcare also did not materialize.  And though some bills for clinical trial regulations, stricter drug laws, and codifying the rights of the mentally ill were proposed, they did not pass Parliament.

The government is also currently planning an amendment to rule 122 (E) of the Drugs and Cosmetics Act (1945).  The proposal would categorize products with new drug delivery systems (NDDS) as “new drugs.”  These NDDS products improve existing drug formulations by changing the delivery mechanism — such as by adding timed-release delivery — to make the pharmaceutical more efficient.  The market in India for NDDS products is estimated to be up to 25% with an annual growth rate of 9%.

Categorizing NDDS products as “new drugs” — though not Investigation New Drugs (INDs) — would mean that their pharmaceutical companies, like Torrent Pharma and Ranbaxy, would no longer be able to bypass additional regulatory monitoring and clinical trials.  The proposed amendment would also include all vaccines as well as recombinant DNA (r-DNA) derived drugs.  It is likely that this change would result in increased drug development costs for companies making NDDS products and delayed NDDS drug launches.

Another worrying trend is the government ruling certain Western companies’ patents invalid or canceling exclusive sales rights on valid patents because generic companies can provide medicines much more cheaply.  A government committee is expected to announce the initiation of a formal procedure to cancel patents on 15 other medications.

Roche Holdings surrendered its Herceptin patent in 2013 after government threats to allow generic production regardless — and the Indian drugmaker Biocon announced in November that it had received government approval to produce a cheaper version, to be released in early 2014.  Other countries are taking note of India’s actions to reduce drug prices; the Philippines and Indonesia also recently announced patent laws based on India’s.