Argentina govt allows imports formulations from India

Argentinian government issued a notification permitting import of generic formulations from Indian pharmaceutical exporters. With this India becomes the 27th country to supply generic formulations to Argentina, a highly regulated market, further establishing India's expertise in this field and proving the capabilities of Indian manufacturers as a supplier of high quality raw materials at the global platform.

For the last 15 years, Argentina imported generic formulations from only 26 countries, listed with them and this move comes as an outcome of the huge effort put by the commerce ministry who had been successful in projecting the qualities of the Indian formulators.

Dr P V Appaji, director general of Pharmexcil, the commerce ministry have been ardently pushing for this matter on behalf of the industry with the Argentinian government, by sending delegates from the ministry and industry to pursue this matter at the earnest with their Argentinian counterparts.

Medical devices industry needs separate set of rules

AdvaMed, an association of medical device manufacturers, stressed that in the light of many regulatory hurdles the industry is facing in India, it is high time for the government to frame a specific set of acts and rules for the medical devices industry. The association welcomed the government’s effort to create a distinction between medical devices and drugs through a separate chapter in the Drugs & Cosmetics (Amendment) Bill, and its commitment to tackling non- communicable diseases.

AdvaMed pointed out that in the long run, a separate Act would enable the industry to effectively address India’s healthcare challenges. Sanjay Banerjee, chair of AdvaMed India said, “For decades in India, the medical device industry has gone unrecognised as a distinct pillar of the healthcare sector. Of the 14000 types of medical devices, only 14 are on the regulator’s list and even these are treated as drugs. There is a misconception here that medical devices and drugs are the same because they are both used to treat diseases. The obfuscation of the two categories in India has limited the ability of the sector to address India’s healthcare needs. There is a major gap between devices used and what is needed.”

Chemist - Shops

the Mumbai chemists withdrew the agitation and shops are open without any time restrictions. But most of the chemist shops still do not have a pharmacist at the counter all the time. And the the FDA commissioner has not stopped his state wide inspection of chemist shops to see that pharmacists are present at the retail counter all the time.

Most of state governments in the country have miserably failed to ensure implementation of section 42 of the Pharmacy Act ever since the section was added to the Act. This section came into effect on September 1,1984 to end the practice of running  medical shops without qualified persons. The state pharmacy councils and drug control departments of Andhra Pradesh, Karnataka and Kerala had also conducted similar raids against retail chemists for violation of Section 42 in the past. But the practice continues even today and most of the 6 lakh retail chemist shops in the country are still being managed by salesmen with some superficial knowledge of medicines. Absence of a qualified pharmacist at the counter can definitely affect the quality of service by way of unprofessional counselling leading to wrong dispensing and over medication.

This needs to be strictly curbed in the interest of public health. Section 42 is an ideal piece of legislation and all the developed and most of the developing countries have the practice of keeping full time pharmacists at retail counters. In India, owners of chemist shops are blocking the implementation of the Section from the very beginning. Their objection to have a full time pharmacist at the counter is the 'unbearable' costs of appointing a pharmacist throughout the working hours in a chemist shop. That may or may not be true. But, when anyone venture into a business he cannot bypass the existing laws governing that business. And the enforcement agencies cannot be blind to perpetual violation of the provisions of any Act.


Therefore, both Centre and state governments have to seriously ponder about this lingering issue and have to come out with a right solution without any more delay.

FDI - India

India’s attempt to regulate increasing inflow of foreign direct investments into the pharmaceutical sector does not seem to yield the desired result as yet. Although government allows 100 per cent FDI in pharma sector through automatic approval route in new projects and investments in the existing companies only through the Foreign Investment Promotion Board approval, there has been a steady rise in the number of acquisitions of large Indian pharmaceutical companies over the last ten years.

The first major acquisition in pharma sector was in 2008 when the Japanese giant, Daiichi Sankyo, took control of India’s largest pharma company, Ranbaxy Labs for $4.6 billion. Another major acquisition was of Shantha Biotechnics by the French pharma company Sanofi-Aventis. And the most recent FDI investment was for acquiring Indian generic drugs company, Agila Specialties, by the US based MNC Mylan Inc for a sum of Rs. 5,168 crore.


The government had cleared this deal a couple of months ago. Now, Sanofi is understood to be planning to acquire a medium size company, Elder Pharmaceuticals. FDI in the pharma sector has more than doubled to $1.07 billion during April-August period of this year as against an FDI of  $487 million during April-August 2012, as per the latest data of the Department of Industrial Policy and Promotion. Over 96 per cent of the total FDI in the sector between April 2012 and April 2013 has come into brownfield pharma projects. The situation is scary as MNCs already control 35 per cent of the domestic pharmaceutical business.

India and other emerging markets

Economic Value derived above is based on dynamic assumptions which are likely to change during the course of development. Hence repeating this exercise at regular intervals is a prudent strategy.

Tornado  analysis is a tool used to identify the most impactful or most sensitive assumptions. Number of competitors in the market, probability of success, time to market launch and development costs are the key areas that companies should focus their energy on to maximize drug’s commercial potential.

Managing environmental challenges in India and other emerging markets, While the above process is fairly robust, the real challenge in developing drugs for emerging markets is the understanding of the local environmental and regulatory aspects.

 
Controlled pricing for patented products in India on the basis of procurement prices in UK, Canada, France, Australia, and NZ adjusted for per capita GDP ratio is under discussion by government authorities

Medicines Patents Pool (Gilead for HIV drugs) - voluntary patent licensing to generic companies in exchange for royalties is a new workaround to tackle stricter patent laws in India

Lack of clarity on Orphan status or Breakthrough designation viz-a-viz developed markets continues to be a challenge in designing clinical development strategy for emerging markets

Differential pricing both Inter and Intra country is a viable strategy being pursued for drug pricing in this part of the world. Compulsory Licensing of the patented drugs in countries like India, China, Brazil and Thailand is a known risk impacting the drug pricing.

Clinical trial cost escalations due to compensation issues, audio-visual informed consent and tighter pharmocovigilance cannot be undermined in expense estimations.

Lab Chemicals -Shrinking R&D spend

The declining budget allocation for research and development (R&D) activities due to global economic slump as well as the exorbitant rise in the lab instrument costs have impacted the fortunes of the lab chemicals and equipment sectors.

Specifically for India, the budget allocation for R&D from the Union government has fallen from 15 per cent in 2009 to five per cent in 2013-14. The scientific community now foresees a further dip in the R&D allocation.

There is a serious erosion of confidence among the scientific community as they fear that the abysmal fund crunch would badly hit innovation. The government should understand that research will not yield immediate results and unless there is continuous funding, prospects of innovation is bleak, they point out.

The steep hike in the cost of lab instruments even within weeks is also posing a serious problem. For example Gas Chromatography-Mass Spectrometry (GCMS) instrument costing Rcostings. 35 lakh in mid-2013 has soared to Rs. 46 lakh at present, point a section of scientists.

All is not well from the lab chemical industry and instrumentation supplier perspective also.

The year 2013 was better off, compared to 2012 as many of the Contract Research Organizations (CROs), contract research manufacturing services (CRAMS), or stand alone contract manufacturing organizations (CMOs) and pharma companies performed better. The year 2013 also witnessed the consolidation of the lab chemicals sector with changes at management levels.

Though the market growth is close to double digit, majority of the lab chemical companies depend on pharma or related industries for business development. In 2014, we expect Indian lab chemical manufacturers to move on to production of pharmacopeial grade chemicals like USP- NF, PhEur and BP. There is some optimism that in 2014 , after country’s general elections, there could be an increase in the fund allocation for research.

India, China takes lead in Research

The softpower of the globe which was the preserve of the West of centuries is fast shifting to the East as emerging nations led by India and China are enhancing their science, education and technology policies says a research.

According to sturdy the country has seen whopping 146 per cent increase in its research output in the past decade alone, taking its globe share to 3.6 percent.

 Over the past decade the country has increased its scientific research output by a whopping 146 per cent and  account for 3.6 per cent of the total world share of researches increased of its world share by 1.1 percentage .

According to the report the country produced twice a many published research papers in 2012.  The study on G20 nations  compared the research and innovation land scape of the each nations and has found that the US and European Union have dropped in science and innovation impact, while Australia, China, India, France and Britain have gained influence.

Patents - India

US insulin maker and biotech researcher Eli Lilly and co, won the most number of those patents in that period, securing 36 of them, mainly for biological products and compounds to treat diabetes and related diseases.

The patent office granted 3,488 drug patents, of which more than 3,000 were granted to foreign pharma companies. The patents, which cover inventions related to single molecules or groups of compounds or processes leading to development of various medicines, typically allow these companies exclusive marketing rights for such products for at least 15-20 years in India.

The IPO data for 2010-13 also showed that local drug makers and research institutions were granted 230 patents. The names include Cadila Healthcare Ltd, Ranbaxy Laboratories Ltd,  Glenmark  Pharmaceuticals Ltd, Wockhardt Ltd and the state-run Council of Scientific and Industrial Research.

India, which follows a stricter patent regime than the US and European Union, has been at the receiving end of criticism for turning down several patent applications and revoking existing patents following judicial challenges filed by local as well as foreign rivals.

The country’s patent law, unlike that of the US and Europe, doesn’t allow patent grants for drugs invented before 1995—the cut-off year fixed when India reintroduced its product patent regime for pharmaceuticals in 2005 as a signatory to the World Trade Organization’s Trade-Related Intellectual Property Rights (TRIPS) agreement.

The reasoning was that previous inventions are already in the public domain and do not deserve a patent grant.

The country also doesn’t allow invention claims based on simple modification of already known drugs unless the new version is substantially superior in terms of treatment efficacy.

The Indian patent law also empowers interested parties to challenge erroneous patent applications and patent grants.