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Recovery of the Indian Generic Pharmaceutical Export Industry from the Indian Parliamentary Elections HA-5-9-14

 

By Anthony J. Sanders

sanderstony@live.com

 

The Indian general election of May 2014 was the largest, longest, and the most expensive general election in the history of the country and indeed the world. According to the Election Commission of India, 814.5 million people were eligible to vote, with an increase of 100 million voters since the last general election in 2009, making this the largest-ever election in the world. Around 23.1 million or 2.7% of the total eligible voters were aged 18–19.  Running in nine phases from 7 April to 12 May 2014, this was the longest election in the country's history.  In total there were 1.4 million electronic voting machines in 930,000 voting centers.  A total of 8,251 candidates contested for the 543 Lok Sabha seats. The average election turnout over all nine phases was around 66.38%, the highest ever in the history of Indian general elections. The Indian general election of 2014 was held to constitute the 16th Lok Sabha, electing members of parliament for all 543 parliamentary constituencies of India. The results were declared on 16 May, fifteen days before the 15th Lok Sabha completes its constitutional mandate on 31 May 2014. The counting exercise was held at 989 counting centres. The Election Commission of India estimates that the election cost the exchequer INR3500 crore (US$577 million), excluding the expenses incurred for security and by the individual political parties. Parties were expected to spend INR30,500 crore (US$5 billion) in the election, according to the Centre for Media Studies. This was three times the amount spent in the previous election in 2009, and was then the world's second highest after the US$7 billion spent on the 2012 US presidential election.

 

The National Democratic Alliance, led by the Bharatiya Janata Party, won a sweeping victory, taking 336 seats. The BJP itself won 31.0% of all votes and 282 (51.9%) of all seats. It is the first time since the 1984 Indian general elections that a party has won enough seats to govern without the support of other parties. The United Progressive Alliance, led by the Indian National Congress, won 58 seats, 44 (8.1%) of which were won by the Congress, that won 19.3% of all votes. It was the Congress party's worst defeat in a general election. BJP and its allies won the right to form the largest majority government since the 1984 general election. When it became clear that the BJP would win the election, Narendra Modi tweeted, "India has won! Bharat ki Vijay. Ache din ane wale hai (good days are ahead)."  Manmohan Singh tendered his resignation to President Pranab Mukherjee on 17 May. He continued as caretaker Prime Minister, at the request of the President, until 26 May 2014, when Narendra Modi and his cabinet were sworn to office.

 

Since the last general election in 2009, the anti-corruption movement by Anna Hazare, and other similar moves by Baba Ramdev and Arvind Kejriwal(founder of Aam Aadmi Party ), gathered momentum and political interest.  Kejriwal went on to form a separate political party, Aam Aadmi Party in November 2012. The 2012 presidential election, resulted in Pranab Mukherjee of Indian National Congress becoming the President. The Telangana movement for a separate Telangana state from Andhra Pradesh also continued with agitations, including the initial central government decision to grant statehood and then rescind it after counter-protests. Andhra politics was further shaken following the death of its chief minister, Y. S. R. Reddy. His son, Y. S. Jaganmohan Reddy, then broke from the INC and founded the YSR Congress taking several politicians with him.  The final session of parliament started on 6 February and ended on 21 February. Amongst the agenda in the final session was passing the The Lokpal and Lokayuktas Bill, 2013 in tackling corruption and the creation of Telangana. On 30 July 2013, the Congress Working Committee unanimously passed a resolution for the creation of Telangana. Telangana Rashtra Samiti (TRS) welcomed the decision. YSR Congress party leader Jaganmohan Reddy however opposed the decision and in agitation against it, all its MLAs resigned over the issue. The BJP national spokesperson Prakash Javadekar suggested that the INC's move was under pressure and that BJP "will watch till Telangana is formed." In February, Chief Minister of Andhra Pradesh Kiran Kumar Reddy resigned over the proposal to partition the region. The conflicting views of the political parties thus made the Telangana issue a crucial one in the elections.

 

The country's economic indicators were performing well in advance of the result in expectation of a BJP win, on the perception that Modi is business-friendly. The benchmark BSE Sensex and CNX Nifty indexes hit record highs and the Indian rupee strengthened following months of poor performance. On the result day, as early vote counts gave the BJP a majority lead, the Sensex reached a record high of 25,375.63 points, ending the day at a new closing high of 24,121.74. The Nifty reached a record high of 7,563.50, before ending the day at a new closing high of 7,203. The Indian rupee rose to an 11-month high of 58.62 against the US dollar and closed at 58.79. The price of onions, a staple in Indian cuisine, faced a dramatic increase. In the lead up to the election, consumer price inflation increased more than expected while, paradoxically, industrial production fell by more than expected causing a dilemma amid slowing growth. The price of salt was also indicative of general food inflation. The election reportedly boosted the hospitality sector as, according to ASSOCHAM, tourist arrivals from the countries such as the US, UK, France, Singapore and the U.A.E. have gone up by 10–15, while the movement of domestic tourists jumped by 62%.  Generics-discount.com the online exporter of pharmaceutical drugs from a number of competitive full-service pharmaceutical manufacturing plants disappeared without a trace at the time of the elections.  Drugs were counterfeited in the United States but they were adulterated, misbranded and switched without informed consent.  This loss of access to necessary medicine is cause for concern to the new draft Statement of the United Nations which calls for election of a Secretary and ratification of the constitutive document and international tax proposals.  It is hoped that the United Nations, the World Intellectual Property Organization (WIPO) in this case, make reasonable efforts to get the Indian pharmaceutical export industry back online.  We won’t know if India has elected a democracy or remains in a state of anarchy from the elections.  It seems reasonable to speculate that there was a large increase in domestic demand for antibiotics, and other medicines, after the tissue damage of toxic and viral politics became infected by bacteria and due to the appreciation the purchasing power of the rupee increased and export earnings decreased.

 

The Pharmaceutical industry in India is the world's third-largest in terms of volume. According to Department of Pharmaceuticals of the Indian Ministry of Chemicals and Fertilizers, the total turnover of India's pharmaceuticals industry between 2008 and September 2009 was US$21.04 billion. While the domestic market was worth US$12.26 billion. The industry holds a market share of $14 billion in the United States.  Exports of pharmaceuticals products from India increased from US$6.23 billion in 2006–07 to US$8.7 billion in 2008–09 a combined annual growth rate of 21.25%. According to PricewaterhouseCoopers (PWC) in 2010, India joined among the league of top 10 global pharmaceuticals markets in terms of sales by 2020 with value reaching US$50 billion.  In 2002, over 20,000 registered drug manufacturers in India sold $9 billion worth of formulations and bulk drugs. 85% of these formulations were sold in India while over 60% of the bulk drugs were exported, mostly to the United States and Russia. Most of the players in the market are small-to-medium enterprises; 250 of the largest companies control 70% of the Indian market. Thanks to the 1970 Patent Act, multinationals represent only 35% of the market, down from 70% thirty years ago.  There are 74 US FDA-approved manufacturing facilities in India, more than in any other country outside the U.S, and in 2005, almost 20% of all Abbreviated New Drug Applications (ANDA) to the FDA are expected to be filed by Indian companies.  As it expands its core business, the industry is being forced to adapt its business model to recent changes in the operating environment. The first and most significant change was the 1 January 2005 enactment of an amendment to India’s patent law that reinstated product patents for the first time since 1972. The legislation took effect on the deadline set by the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which mandated patent protection on both products and processes for a period of 20 years. Under this new law, India will be forced to recognize not only new patents but also any patents filed after 1 January 1995. Indian companies achieved their status in the domestic market by breaking these product patents, and it is estimated that within the next few years, they will lose $650 million of the local generics market to patent-holders.  In the domestic market, this new patent legislation has resulted in fairly clear segmentation. The multinationals narrowed their focus onto high-end patients who make up only 12% of the market, taking advantage of their newly bestowed patent protection. Meanwhile, Indian firms have chosen to take their existing product portfolios and target semi-urban and rural populations. 

 

The urban flight of pharmacists and disappearance of generics-discount.com is believed to be the result of a patent protection grab by multinationals pursuant to Indian patent protection law under the corrupt influence of the refugee perpetuating White House Intellectual Property (WHIP) Enforcement Coordinator that needs to be immediately abolished under the Slavery Convention of 1926 and must not interfere with the recovery of the Indian generic pharmaceutical export industry.  Most of the drugs sold by Generics-discount.com were patented in the 1960s, more than 50 years ago, not qualifying for 20 years of patent protection of the WTO.  Wherefore, there is no known legal justification for why generics-discount.com is offline.  It is possible that some or most of the drug manufacturing equipment was patented less than 20 years ago but if they purchased it, or acquired it using legal methods, the high tech-product belongs to the firm that owns it, and within the limits of applicable laws, free to produce standard high quality generic drugs in sealed packages which are sold to individual humans worldwide.  The presence of counterfeit, nauseatingly adulterated and misbranded Indian drugs in the United States may be the result of unethically confiscated pharmaceutical manufacturing machinery from India, which has, so far unsuccessfully, been targeted for confiscation by the U.S. Food and Drug Administration (FDA) under 24USC(4)§225h (b-2) should the Buy American provisions at §225h (b, e, d) procure the drug counterfeiting equipment.  Notwithstanding, the United States is compelled to pay some sort of compensation for business losses incurred to the Indian online pharmaceutical exporting industry for the drug counterfeiting operation in the United States, and to provide incentive to get the more than $5 billion annual Indian pharmaceutical export market to the United States back online. 

 

All the information contained in this news report regarding the Indian Parliamentary elections of 2014 comes from Wikipedia.  Further, scientific and legal citation and analysis of this article may be commissioned without charge by making a written request to the author at the email address at the top of this article.