The new drug approval in India is now in demand and primary drive of the rules governing approvals of these products is to safeguard public health. Accordingly, it is the role of statutory regulatory authorities to ensure that pharmaceutical companies comply with regulations. Drug approval process can be understood as an optimized procedure by which a new drug molecule is formally approved by drug authority for a person or organization interested to launch a drug product for commercialization.
The IPM is valued at Rs 1.
Owing to robust historical growth, many MNC companies have active presence in the Indian pharma space. The IPM is highly fragmented with about 24, players in the organised sector.
The top ten companies including domestic and MNC companies make up for more than a third of the market.
Besides the domestic market, Indian pharma companies also has a large chunk of their revenues coming from exports. Major companies have revenues coming in from the sale of intermediates, active pharmaceutical ingredients APIsand formulations in various global markets. These include developed markets like US, Europe and Japan and semi developed markets across the world.
Biopharmaceuticals is also increasingly becoming an area of interest given the complexity in manufacture and limited competition. The past few years have been glorious ones for the Indian companies, as major blockbusters lost their patent protection, paving way for generics.
However, every passing year is leaving lower patented drug opportunities for the Indian companies for the launch of generics. The companies are spending more to establish niche product portfolios for the future.
How to Research the Pharmaceutical Sector Key Points Supply Higher for traditional therapeutic segments, this is typical of a developing market. Relatively lower for lifestyle segment. Demand Very high for certain therapeutic segments.
Will change as life expectancy, literacy increases. Barriers to entry Distribution network, patents, developing and manufacturing capabilities, Bargaining power of suppliers Varies from market to market For instance, consolidation in US has led to pricing war in generics, In India, distributors are increasingly pushing branded products in a bid to earn higher margins.
Bargaining power of buyers High, a fragmented industry has ensured that there is widespread competition in almost all product segments. Currently, the domestic market is also protected by the DPCO.
On the domestic front, the year was a mixed bag for Indian companies. This had resulted in poor performance being reported by major MNC companies.
Their performance was even below the domestic players. The trend continued for FY17 too. While the ban is still contested in courts, both domestic and MNC companies saw sluggish growth.
Given these challenges, the MNC companies have been taking various measures to improve their margins. In the US, generic companies witnessed mixed growth. While some of the companies benefited from low competition launches, others got impacted by delay in approvals.
Though there were not many blockbuster launches during the year, there were just a handful companies that displayed robust performance. On the other hand, Indian companies having presence in emerging markets were too impacted. The currencies of major countries witnessed sharp depreciation, leading to poor realisations.
Further, slowdown in some countries impacted their growth. Over and above, the companies also witnessed pressures owing to slower approval rate. This was seen in regions of Latin America.A strong leadership 24 THE INDIAN PHARMACIST | Vol. XII | No. 11 | MAY Current Regulatory Scenario in India from a united Indian pharma Guidelines on Similar (also referred to as living modiﬁed industry and a joint national Biologics, , prepared by organisms) and products thereof in approach by the Ministries and CDSCO and Department.
Jan 01, · 4. Indian pharmaceutical industry possesses excellent chemistry and process reengineering skills. This adds to the competitive advantage of the Indian companies.
The strength in chemistry skill helps Indian companies to develop processes, which are cost effective. Weaknesses: 1. The Indian pharma companies are marred by the price regulation. CURRENT SCENARIO India is now among the top five pharmaceutical emerging markets.
The Indian Pharmaceutical Industry is estimated to grow at 20 % compound annual growth rate (CAGR) over the next five years. There will be new drug launches, new drug . prices scenario in the country from one of the highest in the world to one of the lowest in the world 4, reducing the time lag for the introduction of a drug in India .
Pharma companies, importantly the ones operating in India, will need to realign their quality and compliance structure to conform to the constantly evolving regulatory guidelines.
With the FDA and other regulators broadening the scope of compliance requirements, it helps if companies have a holistic approach and make regulatory compliance part. pharmaceutical industry, only a mere 30% of Indian population has secured access to modern medications.
Until the entire population has access to drugs India has to.