India is now the 3^rd largest by volume and 10^th largest by value in case of production of drugs and Pharmaceuticals. Presently India is contributing 8 percent global production. India recorded its turnover of $40 billion in 2018-2019 and it is expected that it will cross 55 billion US$ by 2030. India exported $19.13 billion worth of drugs and Pharmaceuticals in 2018-2019 among 350 countries. Indian pharmaceutical Industry recorded a growth of 9.4 percent CAGR in 2018-2019, which is one of the highest among industries. India is producing almost 50 percent of vaccines consumed worldwide and exported vaccines to about 250 countries. This showed the strength of Indian Pharmaceutical industries in case of pharmaceutical industry. The same trend is continuing during the Covid pandemic situation.

During this Covid-19 pandemic about 19.6 crore people has been infected and 42.0 lakh died globally and in India 3.1 crore people infected and 4.2 lakh died.

Role reversal:

During this covid period Indian pharmaceutical industry showed much progress in drug development and innovation by way of getting emergency approval of several drugs and vaccines for fighting Covid-19.

Indian firms conducted clinical trials of several drugs in Indian population and marketed after getting emergency approval for use in Covid patients. The following drugs have got approval from Drugs ControllerGeneral of India (DCGI) and marketed for use in several conditions of Covid patients which are as follows-

Sr. no.	Drug	Inventor	Repurposed	Covid-19	Date of Approval
1.	Remdesivir 100 mg Injection	Gelad Sciences (USA), for Ebola	Gelad, Hetero and 19 more firm is manufacturing subsequently	For emergency use for hospitalized patients suffering from Covid‐19. In these cases, informed consent of the patient or his /her representative in the prescribed form is mandatory before initiating the treatment.	01.06.2020 (Gelad) 20th June 2020 (Hetero)
2.	Favipiravir 200 mg Tablet	Favipiravir is an anti-influenza drug which was developed by FUJIFILM Toyama Chemical Co., Ltd, Japan	Glenmark etc.	Mild to moderate Covid‐19 patients in India. In both the cases, informed consent of the patient or his /her representative in the prescribed form is mandatory before initiating the treatment.	19thJune 2020
3.	Itolizumab injection	Cuba Biocon (Psoriasis since 2013)	Biocon	Restricted Emergency Use of the drug for the treatment of Cytokine Release Syndrome (CRS) in moderate to severe acute respiratory distress syndrome (ADRS) patients due to COVID-19	11th July 2020
4.	Tocilizumab iv Injection	Roche Originally used for Arthritis	Cipla	Slow down the cytokine response in COVID-19 patients by modulating a protein called IL6
5.	Dexamethasone	Old drug	Several manufacturers	For patients on ventilators, the treatment was shown to reduce mortality by about one third, and for patients requiring only oxygen, mortality was cut by about one fifth.	27th June 2020

India has made notable progress in case of innovating vaccines for Covid-19 and its manufacturing. Bharat Biotech in collaboration with Indian Council for Medical Research (ICMR) – National Institute of Virology (NIV) has invented a Covid vaccine having brand name Covaxin and marketing for use after receiving approval from Drugs Controller General of India (DCGI) on 3^rd January 2021. This Covid vaccine has been developed indigenously in India and now approved by more than 14 regulatory agencies. It is expected it will be listed by World Health Organization (WHO) within a month. This is a unique occasion where a research laboratory in Government sector joined hand with a private entrepreneur for innovation of a vaccine.

Similarly, Serum Institute of India has joined with AstraZeneca and developed technology for manufacturing another Covid vaccine and marketed with a Brand name Covishield which is being available in several countries throughout the world.Dr. Reddy’s joined hand with RFID and Gamaleya National Research Center of Russia and conducted clinical trials of Sputnik-V in India and Sputnik V is in use in India.

Using these three Covid-19 vaccines India delivered 46.20 crore doses and made full vaccination of 10.20 crore Indian people (7% of population) till 29^th July 2021.

A good number of Covid vaccines are under pipeline in India. One of them is an rDNA vaccine is under phase three clinical trial by Zydus and it is expected that it will get approval from DCGI very soon.

Government policy change and amendment of Rule for improving access to essential medicines and vaccines:

Change in Government policies and amendment of Drug Rules have given opportunities for improving access to medicines and vaccines. The newly introduced New Drugs and Clinical trial Rules have provisions to market drugs and vaccines under rule 75 (7) without local clinical trials with prior permission of the Central licensing authority (DCGI) which states that- “(7) The local clinical trial may not be required to be submitted along with the application referred to in sub-rule

(1) if, _

(i) the new drug is approved and marketed in countries specified by the Central Licensing Authorityunder rule 101 and if no major unexpected serious adverse events have been reported; or

(ii) the application is for import of a new drug for which the Central Licensing Authority had alreadygranted permission to conduct a global clinical trial which is ongoing in India and in the meantime suchnew drug has been approved for marketing in a country specified under rule 101; and

(iii) there is no probability or evidence, on the basis of existing knowledge, of difference in Indianpopulation of the enzymes or gene involved in the metabolism of the new drug or any factor affectingpharmacokinetics and pharmacodynamics, safety and efficacy of the new drug; and

(iv) the applicant has given an undertaking in writing to conduct Phase IV clinical trial to

establish safety and effectiveness of such new drug as per design approved by the Central LicensingAuthority:

Provided that the Central Licensing Authority may relax this condition, where the drug is

indicated in life threatening or serious diseases or diseases of special relevance to Indian health scenarioor for a condition which is unmet need in India such as XDR tuberculosis, hepatitis C, H1N1, dengue,malaria, HIV, or for the rare diseases for which drugs are not available or available at a high cost or if it is an orphan drug.”

Thereafter CDSCO has published a guideline in this matter and the process of approving new vaccines becomes easier. This guideline stated that no local clinical trials are required if a vaccine for Covid-19 already approved by USFDA, MHRA, PDMA Japan and listed by WHO for emergency use for Covid-19. These two steps helpquick approval for emergency use of vaccines already approved by USFDA, MHRA, PDMA Japan and WHO listed Covid-19 vaccines. Using these provisions Covid -19 vaccines developed by Moderna in US already got approval for import by Cipla limited and hope that some more vaccines will be available in India in future using these provisions.

New Government schemesunder “Atmanirbhar Bharat” mission:  

This mission was launched by Government of India in the year 2020 to make Indian Industries self-reliant. Atmanirbhar Bharat will go beyond self-sufficiency to the pharmaceutical Industry of India, both in case of pharmaceutical products and Active Principal Ingredients (APIs). Along with accelerating domestic manufacturing, it will facilitate innovation and expand the global export base to create ‘Brand India’ in the global pharmaceutical space.

The government of India has taken active steps by releasing the Production Linked Incentive (PLI 1.0 and 2.0) schemes to take forward the Atmanirbhar mission for the pharmaceutical industry. These initiatives will be important to build on the strength of the Indian pharmaceutical industry to manufacture high quality affordable medicines and be a dependable supplier around the globe for the benefit of the patients.

About the authors

Dr. Subhash C Mandal is Vice President   & Chairman, Regulatory Affairs Division, Indian Pharmaceutical Association, Kalina, Santacruz (East), Mumbai-400098.

Mrs. Manjiri Ghara is Vice President & Chairman, Community Pharmacy Division, Indian Pharmaceutical Association, Kalina, Santacruz (East), Mumbai-400098

Corresponding Author: Dr. Subhash C Mandal, E- mail: subhash.mandaldr@gmail.com