Tides in Indian Pharma

Tides in Indian Pharma

by Levin Thomas( Asst Professor,Dept of pharmacy practice,Alshifa college of pharmacy.

1. Union Budget 2015: No big gains for Pharma Sector

The government of India has announced 297 billion rupees in the union budget allocation (2015-16), which is roughly 2 per cent more than its previous financial year for its health sector. USA spends 8.3 per cent of its budgetary provision for the health sector; China spends 3 per cent of its GDP while India spends merely 1 per cent of its GDP for the health sector. 

In the Union budget 2015, the Indian pharmaceutical industry which has been amongst the fastest growing sectors in India, hasn't yet again received any priority. Overall, the budget fell short of any kind of road map for the pharma sector in the form of reforms that would incentivize R&D or manufacturing and boost exports and innovation. To encourage innovation, in-house R&D exemption limit was expected to be raised from 200 percent to 250 percent. Further there is no direct funding/support for research and development/ innovation in the budget. Further, reduction in minimum alternate tax (MAT) benefit has not been extended for R&D.

Introduction of three new National Institutes of Pharmaceutical Education & Research and two Institutes of Science & Education Research is considered to be positive move. Prices of some medicines as well as medical devices are likely to dip with the government exempting drugs and pharmaceuticals from education cess. The exclusion has brought down the excise duty on pharmaceuticals from 6.18% to 6%, prompting the drug price regulator to ask companies to immediately pass on the benefit to consumers by reducing the MRP of the drugs.

The Union Budget was lauded for correcting the inverted duty structure on the pharma sector.  An inverted duty structure is one in which the import duty on a finished product is lower than that on the raw material or intermediate product.  But this is a big challenge for the pharmaceutical industries in India. As on date, India imports majority of the raw materials for drug manufacturing on cheap rates from China. But in case the raw material duty is brought down to a great extent, it will be a challenge to manufacture raw materials (active pharmaceutical ingredients) in the domestic market.

 As per the prediction of McKinsey, the Indian pharmaceutical industry has the growth prospect of doubling itself within 6 years. At this moment it is worth US$ 24 billion and by 2020 it is optimised to be US$ 55. The budget however did not have any major direct positive effects on the rapidly escalating pharma sector.

2. Bar code on drug packaging to track and trace authenticity

To ensure medicines sold in the country are genuine products, the health ministry has developed a 'Track and Trace' mechanism which will enable consumers to check safety and authenticity of a drug through the internet. Under the system, the primary, secondary and tertiary packs of medicines will carry a unique bar code, which will be allotted to each manufacturer. Consumers, buying medicines from retail pharmacy store, can use the bar code on the pack on internet to check information about the source of manufacturing of the product, whether it is an approved drug, it's date of expiry as well as price fixed by the government etc. The move is significant because of the highly fragmented Indian pharmaceutical market, pegged at around Rs 89,000 crore annually. The huge size of the market makes it difficult for regulators and monitoring agencies to track medicines, mainly in rural areas and distant villages. This leads to a potential risk of spurious, inefficacious and low quality medicines being sold in the market. While the government is yet to finalise a date for launching the 'Track and Trace' system in the local market, the health ministry has announced that companies will be given a reasonable time for transition to the new packaging system and that compliance will be mandatory for all drug manufacturers. Now, the government is also working to create an integrated database with all details of a product, which will enable tracking and monitoring of these products. 

3. Developments for Swine Flu Treatment

According to the latest health ministry data released, the total number of deaths due to HINI virus (swine flu) has now reached 812 while 13,688 people have been affected with the infection across the country. Out of 4,318 patients, who tested positive for the HINI virus, 212 have died since 1^st January 2015.

With the deadly H1N1 now a global pandemic, nations across the world have started to stockpile millions of doses of Oseltamivir, the only known antiviral drug that fights HINI infection. India is now capable of indigenously producing shikimic acid - the most vital ingredient used to make Oseltamivir. Department of Health Research (DHR) under the Union Ministry of Health and Family Welfare had undertaken a project in 2010 to produce the compound, which is now successful by  coming up with new indigenous processes of shikimic acid production for large-scale validation. Commercial production of the drug is being looked in the process. In the pharmaceutical industry, shikimic acid is derived from the Chinese star anise (Illicium verum), an ancient cooking spice; the herb is also used in traditional Chinese medicine. This fruit yields 3-7 per cent of its weight as the acid, which is further synthesised into crystals to be useful as a tablet. It is used as a base ingredient for production of Oseltamivir. Shikimic acid is converted in Diethyle Ketal intermediate, which is then reduced in two steps to an epoxide that is finally transformed into Oseltamivir.

4. New Drugs approved in India

Sl.  No.	Drugs	Indications
1.	Lixisenatide pre-filled solution for injection 10µg/20 µg	For the treatment of adults with type 2 diabetes mellitus in combination with a basal insulin alone or metformin, or in combination with sulphonyl urea.
2.	Bedaquiline Tablet. 100 mg	In adults (≥ 18 years), as part of combination therapy of pulmonary tuberculosis due to multi-drug resistant Mycobacterium tuberculosis.
3.	Sofosbuvir Tablet 400 mg	In combination with other medicinal products for the treatment of chronic hepatitis C in adults.