According to a new market research report from companiesandmarkets.com, the $14.23 billion Indian pharmaceutical market is forecast to reach a value of $44.99 billion by 2018, representing a CAGR of 12.2 percent. The main drivers of growth are a booming economy, increasing access to medicines, more investment in healthcare infrastructure and a greater incidence of chronic diseases.
The report notes that India’s intellectual property IP regime is far below international standards; however, there are signs that the situation is changing. In August 2009, health activists and some generic drug companies severely criticized the Indian Commerce Ministry’s decision to accept the Mashelkar committee’s recommendations to grant patents to new drugs.
The adoption of the recommendations indicates that new patents will be allowed on incremental innovation under Section 3(d) of the Indian Patent Act, in the event that the candidate drug offers enhanced therapeutic efficacy. Patent experts supported the decision as it is in line with international norms. Pharmaceutical regulations are rapidly improving in India. In July 2009, the Indian Department of Biotechnology (DBT) planned to create a separate IP regulator for the biotechnology sector. The National Biotechnology Regulatory Board would be responsible for identifying and controlling drugs and vaccines which are developed from natural sources.
That same month, the Drug Controller General of India (DCGI) identified six research and development (R&D) centers in which new drugs will be tested before they are launched. Meanwhile, in May 2009 the DCGI decided to withdraw the powers given to state-level regulators to issue export quality licenses, which are called Certificates of Pharmaceutical Products. The move was designed to centralize and standardize procedures. Unfortunately, India’s pharmaceutical industry is gradually developing an undesirable reputation for producing sub-standard medicines. During Q3 2009, regulators in the US and UK have blacklisted select batches of drugs made by firms based in the South Asian country.
The report also noted that due to the absence of some form of government-provided universal healthcare, India’s health insurance market is one of the most promising sectors in the world. This was underlined in June 2009, when India-based Religare Enterprises signed an agreement with Swiss Re to establish a joint venture with an initial investment of $100million. Operations are expected to start in 2010. At that time, Swiss Re was already present in the India health insurance market, holding a 26 percent stake (the maximum permissible) in TTK Healthcare Services.
The report notes that India’s intellectual property IP regime is far below international standards; however, there are signs that the situation is changing. In August 2009, health activists and some generic drug companies severely criticized the Indian Commerce Ministry’s decision to accept the Mashelkar committee’s recommendations to grant patents to new drugs.
The adoption of the recommendations indicates that new patents will be allowed on incremental innovation under Section 3(d) of the Indian Patent Act, in the event that the candidate drug offers enhanced therapeutic efficacy. Patent experts supported the decision as it is in line with international norms. Pharmaceutical regulations are rapidly improving in India. In July 2009, the Indian Department of Biotechnology (DBT) planned to create a separate IP regulator for the biotechnology sector. The National Biotechnology Regulatory Board would be responsible for identifying and controlling drugs and vaccines which are developed from natural sources.
That same month, the Drug Controller General of India (DCGI) identified six research and development (R&D) centers in which new drugs will be tested before they are launched. Meanwhile, in May 2009 the DCGI decided to withdraw the powers given to state-level regulators to issue export quality licenses, which are called Certificates of Pharmaceutical Products. The move was designed to centralize and standardize procedures. Unfortunately, India’s pharmaceutical industry is gradually developing an undesirable reputation for producing sub-standard medicines. During Q3 2009, regulators in the US and UK have blacklisted select batches of drugs made by firms based in the South Asian country.
The report also noted that due to the absence of some form of government-provided universal healthcare, India’s health insurance market is one of the most promising sectors in the world. This was underlined in June 2009, when India-based Religare Enterprises signed an agreement with Swiss Re to establish a joint venture with an initial investment of $100million. Operations are expected to start in 2010. At that time, Swiss Re was already present in the India health insurance market, holding a 26 percent stake (the maximum permissible) in TTK Healthcare Services.
No comments:
Post a Comment