Pharma Legal and Compliance Summit 2015 - an insight into the Indian pharma industry

Published: 2-Sep-2015

The pharmaceutical industry has been one of India's most vibrant and forward moving sectors of the economy. At the same time, it has come up against roadblocks in terms of the stringent legal and regulatory environs of the country


India has achieved an eminent global position in pharma sector: the Indian pharmaceuticals market is third largest in terms of volume and thirteenth largest in terms of value, according to a pharmaceuticals sector analysis report by equity master. The country also has a huge pool of scientists and engineers who have the potential to take the industry to a very high level. The market is dominated by branded generics, which constitute 70-80% cent of the market. Considered to be a highly fragmented industry, consolidation has increasingly become an important feature of the Indian pharmaceutical market.

Although the pharmaceutical industry has been one of the most dynamic sectors of the Indian economy, it has come up against a number of roadblocks in terms of the stringent legal and regulatory environs of the country.

The Pharma Legal and Compliance Summit 2015, which will be held at The Leela, Mumbai on 16 October, will address the legal hassles and challenges.

Compliance is the key focus of the summit's keynote session. The session encompasses various issues - from the manufacturing hubs to the doorstep of the pharmacist. Some players are still struggling to understand the regulatory aspects of compliance, even though none of them would actually admit to non-compliance.

The creation of intellectual property is where the challenge begins: protecting an asset for successful monetisation is the key to standing apart. The summit session elaborates on all possible aspects of intellectual property, including the implementation phase and sustaining commercial value.

India has witnessed a number of notable mergers and acquisitions and foreign direct investment. Whether it is the pre-existing legal liabilities of an acquisition target or a typical merger deal, a keen eye is required to synchronise all the necessary checks. The summit will consider whether there is a master check list that can be followed.

The patents system in India has been as innovative and inventive as the pharma sector itself. The legal aspects surround the patenting process involve not one but many complex challenges simultaneously. The summit will look at the sector's need for clarity and global regulation to combat the global pressures that India is currently facing.

Regulations should be controlling and not limiting. The summit will consider whether there is an imbalance between the needs of the patient and those of the industry, and will ask whether regulations should be reviewed from a global perspective.

For more details visit www.plcs.co.in or contact Bhupinder Kaur E: Bhupinder@WitnessLive.in, T: +91-9654155065.

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