Pharmas Having Field Day After Covid-19

Pharmas having a field day after Covid-19

To contain the spread of the novel Coronavirus, pharma companies are on their toes for developing a potential cure. Many Indian Pharmas have also signed agreements and deals with other pharma giants. Besides that, US FDA nods for Indian pharmas are on a spree after Indian generic drugs are in demand.

Crux of the Matter

Drug Deals
In the absence of a Covid-19 vaccine, countries like the USA, Japan, and India have approved emergency use of Remdesivir drug, which is considered to be a potential drug for coronavirus. Zydus Cadila has signed a non-exclusive licensing pact with Gilead Sciences. As per the agreement, Zydus will manufacture and market Remdesivir drugs in 127 countries including India. Moreover, Dr. Reddy’s also signed a deal with Gilead for Remdesivir. In recent times, Gilead Sciences, which has Remdesivir’s patent, has signed multiple deals with pharmas across the world. Following is the list of the pharma with whom Gilead Sciences has signed non-exclusive deals :

  • Indian companies: Cipla, Jubilant Sciences, Hetero Labs, Biocon’s arm Syngene International, Zydus Cadila and Dr. Reddy’s
  • Pakistani companies: Ferozsons Labs
  • Bangladeshi companies: Beximco Pharma
  • Egyptian companies: Eva Pharma

Insulin Glargine
Biocon and Mylan have jointly produced Semglee – insulin glargine injection. Available in a vial and pre-filled pen presentations, it helps control high blood sugar in Type-2 diabetic adults and Type-1 diabetic minors. Till now the price of the insulin in the USA has been so high that many people skipped taking the life-saving doses. But after US Food and Drug Administration (FDA) approved the use of insulin glargine as biologics in the USA, Biocon has prepared itself to launch a biosimilar at a relatively cheaper rate.

The biologic drug is a medicine produced from living organisms or contains components of living organisms. Biosimilar is a drug similar to Biologic but not close enough in duplication. Moreover, biosimilars are cheaper with no clinical difference in its effectiveness. Currently Biocon as 28 biosimilar molecules in different stages of development. Biocon launched its first biosimilar in 2016.

AZD1222 Covid Vaccine
AstraZeneca PLC (AZ) has signed a contract with European governments to supply 400 million doses of the vaccine. AZD1222 is its potential vaccine for Coronavirus. The British Medicines and Healthcare products Regulatory Agency has approved the start of Phase III trials and the first delivery of the vaccine is expected by the end of 2020. The deal is made between AstraZeneca and European nations i.e. France, Germany, Italy, and the Netherlands. Moreover, Other European countries will also be allowed to join the deal. China, Brazil, Japan, and Russia have also expressed interest to get the vaccine.

AZ and Serum Institute of India (SII) signed a licensing agreement to supply 1 billion doses of the Oxford University vaccine to India. AZ will also provide an additional 400 million doses to India. SII will invest $100 million in AZ’s Covid-19 vaccine development

Sun Pharma is testing a plant-derived drug, AQCH. It is derived from tropical, climbing shrub Cocculus Hirsutus and is being considered an important drub against fighting Covid. As of now, the company is conducting trials across 12 centers on 210 patients in India. Other Indian pharma companies, Glenmark Pharmaceuticals, and Strides Pharma Science are also conducting trials for a drug to cure Covid-19.

  • AstraZeneca PLC is an English-Swedish multinational pharmaceutical and biopharmaceutical company founded in 1999 through the merger of the Swedish Astra AB and the English Zeneca Group. In June 2020, the National Institute of Allergy and Infectious Diseases (NIAID) confirmed that the third phase of testing for potential vaccines developed by Oxford University and AstraZeneca would begin in August 2020.
  • Word vaccination comes from vaccinia, a cowpox infection. Ultimately from Latin vacca (“cow”). The term was coined by Edward Jenner who infected people with weakened cowpox viruses (Vaccinia), to immunise them against smallpox. It is now known that vaccinia and cowpox are separate conditions, but at the time of Jenner, they were considered the same condition.
  • Hilary Koprowski was a Polish virologist and immunologist active in the United States of America who demonstrated the world’s first effective live polio vaccine. Koprowski was the target of accusations in the press related to the “OPV AIDS hypothesis”, which posited that the AIDS pandemic originated from live polio vaccines such as Koprowski’s. The case was settled out of court with a formal apology from Rolling Stone magazine.

Indian Pharmaceuticals Step Up VS Covid-19

Indian Pharmaceuticals are making their name for their cooperation and speed of action in the worldwide fight against Covid-19. The companies have established tie-ups with foreign groups for both treatment and vaccines.
Complete Coverage: Coronavirus

Crux of the Matter

Remdesivir Comes to India
American pharmaceuticals giant Gilead Sciences is the developer of Remdesivir, an anti-viral drug. Recent evidence has claimed its “clear cut” impact on Coronavirus. The company recently agreed with 5 companies to allow them to manufacture the drug to supply to 127 countries. The companies are:

  • Cipla
  • Hetero Labs
  • Jubilant Life Sciences
  • Mylan
  • Ferozsons Lab

The first 4 are based in India, while the last one is based in Pakistan. They would be supplying to “low-income and lower-medium-income countries and upper-middle and high-income countries”, including developing nations like Afghanistan, Brazil, India, Pakistan, Thailand etc.

The licenses are royalty-free until WHO declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent Covid-19, whichever is earlier.

Gilead Sciences

India’s Cancer Patients Aid Association has criticized the “granting of monopoly” to one group in times of pandemic. Some health groups are seeking assurance over the drug’s cost, particularly in the “low-income” nations.

The licenses divide the global market into two and profitable markets are retained with Gilead and less profitable markets are given to the five generic companies.

K. Gopakumar, Senior Legal Researcher at Third World Network

Rapid Testing
ICMR’s National Institute of Virology (NIV) has developed ELISA test for Coronavirus. With a sensitivity of 98.7% and specificity of 100%, the test would make checking for the virus swift and accurate. 90 samples can be tested in 1 run which would last up to 2.5 hours. The testing is also safer due to containing inactivated virus, and would make testing available at the district level too. NIV has signed a non-exclusive deal with Zydus-Cadila over ELISA’s mass production. However, NIV can also sign deals with other companies owing to the situation.

Vaccine On Trial
Serum Institute of India (SII) has recently tied-up with Oxford University and US company Codagenix to develop Coronavirus vaccine. Being the world’s largest vaccine producer, making over 1.5 billion doses, SII has started the mass production of vaccine which would be available after its successful testing.

Deal Over HCQ
Hydroxychloroquine (HCQ) is an anti-malarial drug previously considered effective against Coronavirus. On 7 April, India removed restrictions from the export of HCQ after Modi-Trump call. On 11 April, a consignment of more than 3.5 million tablets arrived in US from India.

Approval Spree for Indian Pharmaceuticals
Increasing number of Indian Pharmaceuticals have received approvals from the US Food and Drug Administration (FDA).

  • 26 March: Strides Pharma receives Establishment Inspection Report (EIR) for its Bengaluru plant
  • 1 April: Biocon insulin plant in Malaysia cleared by (FDA) barring minor “voluntary improvements”
  • 2 April: Zydus-Cadila receives FDA approval for Lamotrigine tablets, used to treat seizures
  • 9 April: Dr Reddy’s Lab receives EIR for its Telangana plant
  • 15 April: Lupin pharma receives EIR for its Madhya Pradesh plant from FDA
  • 14 May: Lupin pharma gets EIR for its Vizag plant

  • The Merck Group, commonly known as Merck, is a multinational pharmaceutical, chemical, and life sciences company headquartered in Darmstadt, Germany. Merck was founded in 1668 and is the world’s oldest operating chemical and pharmaceutical company, as well as one of the largest pharmaceutical companies in the world.
  • The Sushruta Samhita is an ancient Sanskrit text on medicine and surgery. The Compendium of Suśruta is one of the foundational texts of Ayurveda (Indian traditional medicine). It is one of the two foundational Hindu texts on the medical profession that have survived from ancient India. It is of great historical importance because it includes historically unique chapters describing surgical training, instruments, and procedures.
  • Apollo Hospitals Enterprise Limited gets its name from one of the most important and complex of the Olympian deities from Greek and Roman mythology, Apollo. Other than being the god of healing and diseases, Apollo has been recognized as a god of archery, music and dance, truth and prophecy, the Sun and light, poetry, and more.

Indian Pharmaceuticals can Make their Mark Amidst COVID-19

Indian Pharmaceuticals have an opportunity amidst COVID-19

Western and South Asian countries prefer India as their medical tourist destination. Though in terms of medical expertise and quality of public health care, countries like South Korea, Taiwan, Singapore, Malaysia and Indonesia offer competition to India, but in terms of affordability of tertiary services, India has been a preferred destination. Indian pharmaceuticals should leverage this opportunity.
Complete Coverage: Coronavirus

Crux of the Matter

Strategic Opportunity for India
India’s existing advantage of large-scale pharmaceutical production allows it to significantly leverage its soft power by investing in the outward growth of the healthcare sectors of other nations by firstly increasing exports, becoming a preferred medical tourist destination and pursue medical diplomacy by providing medical training and technical expertise to many other developing nations.

Apart from the above countries UNICEF and UNITAID also rely heavily on generic drugs manufactured in India for their aid programs and thus there is a great potential for India’s pharmaceutical sector now to increase trade partners both regionally and in other parts of the world.

Indian Pharma’s Muscle in Numbers
According to the Indian Brand Equity Foundation (IBEF), pharmaceutical exports of India from 2012 to 2019 have steadily grown from $10 billion to $19 billion. India accounts for about 10% of world’s pharmaceutical production by volume and 1.5% by value. The industry is the world’s largest supplier of generic drugs and controls around 18% of the global market. It is also a leading producer of vaccines in the world and caters to about 50% of global vaccine demands.

  • India is the largest supplier of generic drugs globally. India’s exports account for 20% of the generic medicines traded. In 2017, the Indian pharmaceutical industry was valued at $33 billion.
  • In 1994, 162 countries including India signed the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, which stipulated that patents had to be given to all inventions including medicines. India succeeded in including a crucial clause to the agreement in the form of the right to grant compulsory licenses (CLs) to others to manufacture drugs in cases where the government felt that the patent holder was not serving the public health interest.
  • Alembic Pharmaceuticals Ltd. is India’s one of the oldest pharma companies. It is based in Vadodara, Gujarat and was founded in 1907. It is the market leader in the macrolides segment of anti-infective drugs in India.

Indian Pharmas Get FDA Approval on the Heels of HCQ Deal

As the US battles the COVID19 pandemic, it is on a spree of improving ties with India. In the last 15 days, 5 Indian pharmaceuticals have received clearance from the US Food and Drug Administration (USFDA).
Complete Coverage: Coronavirus

Crux of the Matter

USFDA on Clearance Spree
In the wake of the Coronavirus pandemic, there has arisen a need for essential medicines in the US. Recently, Prez Trump threatened India with retaliatory measures if it did not deliver Hydroxychloroquine (HCQ) medicine. India delivered. US thanked. Meanwhile, the USFDA has given clearances to 5 leading Indian pharmaceuticals.

  • Zydus – Received clearance for sale of Lamotrigine used to treat seizures
  • Lupin – Its Nagpur manufacturing unit received an establishment inspection report (EIR) from the USFDA. Nagpur facility is its largest and most advanced oral solid dosage manufacturing plant
  • Dr. Reddy’s – Its Miryalaguda plant in Telangana received EIR from USFDA
  • Strides Pharma – Its Bengaluru plant received EIR from USFDA
  • Biocon – Its insulin plant in Malaysia received USFDA nod

It must be noted that this year Indian firms received fewer warnings from the USFDA than American companies. However, the number was up from the previous year. 54 American pharmaceuticals received USFDA warnings in the last fiscal year (US fiscal).

Many political analysts are linking the approvals of the pharmaceuticals to the bargain of HCQ that India delivered to the US.

H1B Visa Extended
The US continued to shower goodness on India by allowing extension of H1B visas of Indian nationals stranded there due to the Coronavirus. Indians who are the largest beneficiaries of the H1B visa can now apply for extension of stay (EOS) or change of status (COS) permits. Delay in filing for extension will be allowed only in extraordinary cases.

  • The First Indian pharmaceutical company to produce HCQ was Bengal Chemicals and Pharmaceutical Limited. Although the company stopped producing this anti-malarial drug decades ago, they have again applied for the license to produce the said drug. This company was founded by Prafulla Chandra Ray who is considered to be the father of Indian chemistry.
  • There are over 20,000 prescription drug products approved for marketing by the USFDA. The body is also responsible for the oversight of more than $2.6 trillion of consumption of food, medical products, and tobacco in the US.
  • Over 3,00,000 Indians work in the USA on H1B Visa. If the employer terminates the contract of an H1B holder employee in the US, the latter needs to find new employment within 60 days to retain their H1B status.