On behalf of TCS iON Direct Academy Channel, I welcome you all to webinar on the topic ‘Pharma Industry – The Warrior of Today’. Let’s start with overview of the topic. 

On behalf of TCS iON Direct Academy Channel, I welcome you all to webinar on the topic ‘Pharma Industry – The Warrior of Today’. Let’s start with overview of the topic.
TCS iON Direct Channel

OVERVIEW OF THE TOPIC

The Indian pharmaceuticals market is the third largest in terms of volume and the 13th largest in terms of value. It has established itself as a global manufacturing and a research hub. The Indian pharmaceuticals market is dominated by generic drugs which constitute nearly 70% of the market, whereas over the counter (OTC) medicines and patented drugs make up to 21% and 9%, respectively.

According to a report :

  • India is the largest supplier of generic medicines globally (20 to 22% of the global export volume)
  • The total drugs & pharmaceuticals export during April 2020 to November 2020 was US$ 15.87 billion and for the month of November 2020 it was US$ 1.99 billion.
  • India has exported US$ 3.89 billion of Bulk Drugs & Drug intermediates in FY20.
  • India has one of the lowest manufacturing costs in the world. It is lower than that of USA and almost half of Europe.

To Understand more about the International exports in Pharma industry we have invited special guest today from the industry.

It’s my pleasure and an honor to welcome and introduce our Guest speaker Director of Taj Pharmaceuticals Group Mr. Shantanu Kumar Singh. Welcome. So, before starting the question answer with our speaker I want to inform our participants that you all can ask questions to speaker by putting question in chat box. Now, let me give you introduction of our speaker today.

Mr. Shantanu Singh is Director of Taj Pharma group looking after International Business Operations, Contract Manufacturing and Sales and other areas. He is also responsible for Management Strategic Consulting including business plan & international sales strategy development, Subsidiary Planning and Implementations, Pharmaceuticals API and Chemicals Research and development. He has worked in more than 40 countries EU – UK, Ireland, Poland, Germany, Austria, Romania, Africa & Russia for International exports of Pharma products. 
He has experience in Product Marketing, Pharma Recruitment, Regulatory Submissions, Dossier Preparation, Qualifications and Validations, WHO/GMP Audits, Compliance and Risk Assessment and R&D Documentation
Once again I welcome Mr. Shantanu Kumar Singh
Mr. Shantanu Kumar Singh is Director of Taj Pharma

Introduction

Mr. Shantanu Singh is Director of Taj Pharma group looking after International Business Operations, Contract Manufacturing and Sales and other areas. He is also responsible for Management Strategic Consulting including business plan & international sales strategy development, Subsidiary Planning and Implementations, Pharmaceuticals API and Chemicals Research and development. He has worked in more than 40 countries EU – UK, Ireland, Poland, Germany, Austria, Romania, Africa & Russia for International exports of Pharma products. 

He has experience in Product Marketing, Pharma Recruitment, Regulatory Submissions, Dossier Preparation, Qualifications and Validations, WHO/GMP Audits, Compliance and Risk Assessment and R&D Documentation

Once again I welcome Mr. Shantanu Kumar Singh

TCS iON: Please tell us about the current scenario of International Exports & what are the 3 opportunities in this sector to focus?

Mr.S.K.SINGH: Pharma exports grew 18.7% in FY21; to $24.44 billion in the financial year ended March 31, spurred by strong demand for the country’s generic drugs.

The Primary Scenario Can be understood by:

  1. Pharma Exports being 2nd Largest Commodity of Indian Exports
  2. Generic Drug formulations, biologicals and Vaccines
  3. Lockdowns and Supply Chain disruptions
  4. Pharma Sector Growth was the best in 8 financial years owing to the essential Covid support products
  5. Major Export Market and Stats

______________________________

  1. Pharma Exports being 2nd Largest Commodity of Indian Exports:

Although the overall pharma market shrieked approx. 2%; yet surge in demand for made-in-India generics, owing to our quality and affordability which met budgetary requirements.

Drug formulations and biologicals were the second-largest commodity exported from India. In the previous fiscal, pharmaceutical exports had increased by 7.57% to $20.58 billion.

  • Generic Drug formulations, biologicals and Vaccines:

We saw a great surge in demand for the affordable generics such as Hydroxychloroquine with Azithromycin globally at the start of pandemic. However, this demand gradually shifted towards Anti-Viral Drugs, Steroids etc. Indian market was also looked upon as a scale up country for the various biologicals and Vaccines such as Astrazeneca Oxford vaccine Covishield; Sputnik vaccine etc.

  • Lock-downs and Supply Chain disruptions:

Although, our nation has faced lockdown of 1.3 billion populations; and our economies coming to full stop to stop the spread of the virus. However, even with all the disruptions and limited percentage of employees; our industries; specially pharma has stood up to the challenge; irrespective of all the logistics issue, staff, labor etc.

  • Pharma Sector Growth was the best in 8 financial years owing to the essential Covid support products

In the previous fiscal, pharmaceutical exports had increased by 7.57% to $20.58 billion. Enthought performance was hurt by lockdowns and supply chain disruptions, aimed post covid era; 18.7% growth was the best in eight financial years owing to the essential Covid support products being outsourced from India.

  • Major Export Market and Stats

North America – Largest Market 34% share
U.S., Canada and Mexico grew 12.6%; 30% share 21.4% respectively
Africa increased 13.4% South Africa emerged as 2nd Largest Market with increase in exports by 28% along with Nigeria, Kenya and Tanzania as other major markets.
Exports to Europe, the third-largest market, was about 11%

Latin America (growth of 14.5%),
CIS countries (23.5% growth) and
Middle East (17.5%).
unexplored markets such as Australia (21%) UAE (43%), Uzbekistan (125%) and Ukraine (40.6%) were also encouraging.

TCS iON: What are the 3 important steps for an MSME to venture into the export market? What are the main export procedures & methods should be taken care of?

Mr.S.K.SINGH: 3 opportunities in this sector to focus:

Generic Formulation Export
Essential Drug Formulations
Vaccine Manufacturing

  1. Generic Formation Export:
    The primary opportunity for India is to export generic equivalent formulations; which can help countries who are already facing budget constraints on a squeezed health care system in the Covid 19 prolonged time.  Indian generics are only 30% of the branded meds cost or less costly than the branded products. Every dollar saved by the semi-regulated countries such as Brazil, Argentina, Peru etc. can be beneficial to the nations. Indian Pharma Industry has played its part in supply of covid support products such as Hydroxychloroquine tabs, Ivermectin tabs and all Covid Support products such as cortisol steroids etc. So huge opportunities for all finished formulation units.
  • Essential Drug Formulations:
    During the prolonged pandemic era; pharma industry has shifted towards more essential formulations and such shall be kept as a more focused area for formulations. Many life style products have lost it demands which was earlier a good line for exports. However, we see a demand curve towards:

    1) Anti-Vial: Remdesivir, Favipiravir
    2) Anti-Biotic: Azithromycin
    3) Anti- pyretic Products  (paracetamol, and the nonsteroidal anti-inflammatory drugs aspirin, ibuprofen, and naproxen)
    4) Cortico-steroids (Dexamethasone, prednisone, methylprednisolone, hydrocortisone)
    5) Anti-
    Parasitic – Ivermectin

Now, Anti-Fungal As well; Leish-maniasis (Mucormycosis; ‘Black Fungus’); products such as Liposomal Amphotericin B, Voriconazole, Fluconazole etc.

  • Vaccine Manufacturing:
    The opportunity also stands for labs and units for small to medium scale Vaccine Manufacturing if the vaccine manufacturing technology is freely available.

TCS iON: What are the 3 important steps for an MSME to venture into the export market? What are the main export procedures & methods should be taken care of?

Mr.S.K.SINGH: 3 important steps for an MSME to venture into the export market?

1) Ultra-modern Manufacturing Units
2) GMP & International Norms
3) Drug Registrations / Plant Inspections / International GMPs

  1. Ultra-modern Manufacturing Units

MSME under the pharmaceuticals industry must have ultra-modern manufacturing units; equipped with modern machines. Pharma Units must evolve to new export market norms and ICH guidelines.
New units must follow
ultra modern GMP panels,
flush doors,
contamination free standard operating procedures,
inter-lock systems and GMP process flow controls
.

The modern GMP practices mandate that products are consistently produced and controlled according to quality standards; the new plants shall be designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

  • GMP & International Norms

GMP checklist should include checks related to the preparation, review, approval and distribution of documentation and records related to the manufacture of any intermediates, active pharmaceutical ingredients (API) and finished products.
GMP include
(1) designing and constructing the facilities and equipment properly and identifying the responsibilities;
(2) following written procedures and instructions;
(3) documenting work;
(4)Product Validation; processes Validation and evaluating the staff performances;
(5) Monitoring and regular
(6) Zone IV (Stability)
(7) Data Integrity / BMR / BPR

  • Drug Registrations / Plant Inspections / International GMPs

Exports shall be exploring from Semi Regulated markets such as Latin America, MENA Regions, Africa, CIS nations, Sea Countries towards regulated markets Australia, U.S., Canada and Europe.
Methods are primarily include making of quality products along with the regulatory documents for the end country in question. Exports are something that has to be built over time along with the quality products. CTD Dossier making, product validation, consistent quality and regular inspections from importing country GMPs. Product is key factor to success in the pharma export markets. 

TCS iON: What are the main 5 main Challenges which Indian Pharma industry is facing?

Mr.S.K.SINGH: 5 main Challenges which Indian Pharma industry is facing?

1)      Raw Material Shortage of Covid Support Raw Material
2)      Raw material dependence on china
3)      Drug Shortages of Essential Covid Support Drug
4)      Drug Price Control in India for finished products
5)      Bulk Drug Price Control of Essential APIs

  1. Raw Material Shortage of Covid Support Raw Material
  2. Covid Drugs (Remdesivir, Favipiravir); jumped from 30% to 200% in prices. Drug Makers have voiced this concern. As this will lead to shortage of key medicines.
  3. The prices of (APIs), such as ivermectin, methylprednisolone, doxycycline, enoxaparin, paracetamol, azithromycin, meropenem and pipratazo, needed for the production of key Covid medicines, have gone up by approximately 30-200 per cent in the past one month, between March to April 2021.
  4. Drug-makers are struggling with the frequent fluctuations in prices and termed the situation as “alarming”.
  5. Traders and manufacturers of these raw materials are quoting different prices, sometimes within a span of four hours. The situation is very bad. If there is no intervention [from the government], there is a high probability of shortages of medicines in the coming months.
  6. The suspension of Chinese cargo services to India, impacting the import of pharmaceutical raw materials, has added to the industry’s worries.
  7. India imports 70 per cent of its pharmaceutical raw materials from China. On 26 April, China suspended for 15 days cargo flights by Sichuan Airlines that had been transporting medical supplies to India. This, according to industry insiders, has led to a hoarding of important pharmaceutical raw materials.
  • Raw material dependence on china
  • Govt looks to boost domestic production of raw ingredients to reduce dependence on china.
  • Production-Linked Incentive scheme that was approved in March to reduce dependence on China.
  • Encourage more drugmakers to apply for the scheme and boost production of active pharmaceutical ingredients (APIs) used in making medicines, such as paracetamol
  • minimum annual production capacity for 10 products, including antibiotics such as tetracycline, neomycin, ciprofloxacin and blood thinning agent, Aspirin.
  • The government assessed the impact of the COVID-19 pandemic on the availability of active pharmaceutical ingredients (API), intermediates and key starting materials (KSM) for which India is critically dependent on China.
  • The new schemes are expected to increase domestic production of KSMs, DIs(drug intermediates) and APIs and reduce the country’s import dependence to a large extent.

It is crucial that, We have to make domestic Bulk Drug and Intermediary manufacturing more attractive to the manufacturers; We could implement free land to such API units, 5 years tax free period, R&D subsidy on New APIs etc. based on such models implemented in many foreign nations such as Russia and CIS to become more self-sufficient.  

  • Drug Shortages of Essential Covid Support Drug
  • Major Covid Support Drug Shortages; such as Remdesivir, Favipiravir, Now, Liposomal amphotericin b – serious fungal infections and leishmaniasis
  • Transportation issue from point A to B and specially in Remote Areas
  • We did not learn from Past year; and were somehow not prepared and stocked to face any Covid Waves in terms of Meds
  • No advance list of vast used meds which should have been manufactured and stocked as a pre-preparation. No Pharma company can be expected to keep such large quantity ready stocks leading to drug shortages
  • Overpricing from Pharmacies and black marketing as a primary issue by small vendors to the individual patients. i.e., Over pricing to the poor people.
  • There is also an issue to precautionary medications; and overstocking, even if they are not severely ill; in a pre-notion that it may run out. Leading to shortage to actually needy admitted patients.
  • Drug Price Control in India for finished products; (National Pharmaceuticals Pricing Authority -NPA)
    a) Drug Price Control of Finished Pharma Product
    While we have seen regular revision of essential drug price control published by DPCO authorities; who is MRP control authority of essential Pharma Products in India. Recently we saw, such to be exercised on Remdesivir, methylprednisolone etc.
  • Bulk Drug Price Control of Essential APIs

However, our price control has not been very helpful unless; API Prices / Bulk Drug Prices of Essential Drug is also caped after careful Evaluation.

Pharma Industry already warned Covid Support Drug Shortage and Price hike / increase of 200% leading to Drug Shortage or High price of essential finished form of the Drug.


The shortage of oxygen needed in manufacturing APIs — India is currently facing a huge shortage of medical oxygen owing to the demands of Covid patients — and shortage in manpower for production, because of the pandemic, are other reasons being forwarded for the short supply of pharmaceutical raw materials.

TCS iON: What are the 5 immediate steps which Indian pharma industry needs to take to overcome these challenges?

Mr.S.K.SINGH: 5 immediate steps which Indian pharma industry needs to take to overcome these challenges

There should be short term and long term steps:

Our System is overburdened and there is no pre-analysis or preparations

  1. Boost of essential drug Shortage products with the caping to the APIs of essential Covid Medicines. Industry shall stock up finished formulations of ramdesvir, favipiravir, ivermectin, methylprednisolone, doxycycline, enoxaparin, paracetamol, azithromycin, meropenem and pipratazo etc. Now, Amphotericin B
  2. Pandemic shall not be looked upon as opportunity and neither such shall be extended to pharma distributors, agents. Reducing of key Pharma products MRP and Pharmacy margins. As these essential products does not need any marketing.
  3. 70 per cent of our pharmaceutical raw materials is from China; Hence, suspended cargo flights shall be resumed via diplomatic channels; or even Special Caro Only Flights can be resumed to control API shortage.
  4. The Pharma Companies shall study the overall pattern of Drug Demand over past year and propose estimates to all stated to keep stocks of essential drugs. Advance list of especial List of Medicines needs to be prepared based on population of states an estimated stock levels shall be decided. A divided batch schedules of these essential drug shall be given to companies to keep manducating and supplying such products. As overnight or week such shortages can not be solved.
  5. Invest in Clinical Trial of Covid Patients to find more alternative drugs which could work. These Trails will provide a large variety of alternatives; which we will already know for Doctors to prescribe and Industry to make sure its viability in an affordable caped price.

TCS iON: What are the 5 immediate steps government should take to support pharma industry?

Mr.S.K.SINGH: 5 immediate steps government should take to support pharma industry

  1. Boost Diplomatic Channel from China to have Special / Regular Cargo Flights to Solve Current intermediary and Bulk Drug Shortage in the industry.
  2. Regulate the API Price of Essential Bulk Drug – Under the National Pharmaceuticals Pricing Authority; at least for Pandemic Period only. Similar to Finished Pharma Goods.
  3.  All Pharmaceuticals Goods shall be exempted from Toll Plaza in the pandemic to ensure effective reach of especial meds.
  4. To Curb the huge escalation in input and transportation cost and their cascading effect on the pharmaceutical value chain throws up severe challenges in maintaining the viability of the pharma business for many of our colleagues.
  5. To also solve the reduced supply of oxygen for raw material manufacturing within the country. The production of many APIs and intermediates — needed for manufacturing drugs — require oxygen supply. But there is limited oxygen supply now.

TCS iON: Please share Your final remarks and key takeaways for the audience please.

Mr.S.K.SINGH: Now, None of the Pharma manufacturing plants are working on full manpower capacity, because either the employees or their family members are infected with Covid. We all need to understand this situation. Our System is overburdened. This cannot be completely called shortage of drugs or something which any one would have predicted with full certainty.

Vaccine and basic preventive medicines shall be freely available only to poor and who cannot afford the cost.
Government (all) is doing good with so many measures; However, none of us could call ourself full experienced or fortune tellers. Whole system is overburdened and Govt. / Pharma Companies / Agents / Doctors / Hospitals / officials on duty /; all need to work hand in hand to get control of this situation.

Free vaccine to people who can afford is not viable; and more than 20% of our population can afford paid vaccination and medicines. This can reduce already burdened government budget and provide finance to the needed people who cannot afford this.

We all need to be now prepared; or rather over prepared with a possible 3rd wave in India. Which is yet uncertain predictivity and yet a possibility of much deadly wave than current one. We need to build oxygen generation plants in large hospitals; and be more equipped for such instances; whilst we control the current covid surge and post covid complications.