Pharma News – 20 January 2021

Leading drugmakers found in the new provisional list released by drug price watchdog of India :

NPPA[1], colloquially referred to as India’s drug price watchdog released the updated provisional list on 11 January 2021. This list details the “overcharging cases” (OC) under litigation. All the cases listed in this date back to 1997, which this watchdog was formed. Albeit being a regular occurrence, the new list baffled many. It included the names of some leading drug makers in India. This list encompassed pharma majors like Cipla, Lupin, Cadila, and Sun Pharma, among others accused of overcharging consumers.

The companies included in this list usually face penalties, which is the sum of the amount allegedly overcharged and the interest. According to this list, the total estimated overcharged amount minus the penalties already paid stands at Rs.6,550 crore. 

The penalty of Cipla is over Rs.3000 crore, while that of Sun Pharma is around Rs.250 crore. Ranbaxy, albeit merging with Sun Pharma in 2015, still has a penalty of Rs.400 crore left.

In 2013, two pharma companies alone contributed to around 50 percent of the total overcharged amount. These companies, namely Cipla and Ranbaxy, had a penalty of Rs.1382 crore and Rs.136.2 crore, respectively.

Based on the latest list, the overcharging penalty of Lupin stands around Rs.67 crore while that of GSK[2] totals Rs.3.42 crore. The total overcharging amount of Cadila is also revealed to be over Rs.34 crore.

The official website also uploaded an office memorandum accompanying this list. Through this, the NPPA announced that it would upload the provisional list of OC cases under litigation for companies to see their case’s status. It further added that the concerned companies might contact them in case of any discrepancies in this regard. It also reiterated that any modification in the list is only feasible if it provides substantial documentary evidence. This feedback is also requested to be submitted within 15 days. 

The NPPA has also explicitly stated that the interest amount had been updated up to 30.11.2020 wherever possible. It further revealed that any payment or part – payment made had been adjusted from the total amount. This can be observed by a variation in the date of updation of interest.

Abbreviation :

• [1] – National Pharmaceutical Pricing Authority
• [2] – GlaxoSmithKline

2. Oxford – AstraZeneca COVID-19 vaccine gets emergency approval in Pakistan :

On 16 January 2021, the DRAP[1] granted approval for Oxford’s emergency use – AstraZeneca’s COVID – 19 vaccine across the country. As per reports from the chief of the NCOC[2], the vaccine is expected to roll out by March 2021.

In the first phase of vaccination, the country plans to vaccinate health care workers and those aged 65 years and above.

Another government official also stated on 15 January 2021 that Pakistan had been in contact with China and other companies to purchase COVID – 19 vaccine. He further added that the government is looking forward to the results of the vaccine produced by the Chinese firm, Cansino. He asserted that this medicine would be registered with the DRAP for procurement if proven successful in the trials. Apart from this, he also stated that international coalition Covax had agreed to provide 50 million doses of free COVID – 19 vaccine to Pakistan.

The total number of COVID – 19 cases spiked to around 519,291 after 2,521 new cases were detected within the past 24 hours. During this period, 43 lives had succumbed to the disease bringing the total fatalities to around 10,951. A government official has also claimed that Pakistan plans to vaccinate at least 70 percent of its total population covering around 70 million citizens.

The NCOC is the country’s coronavirus control body headed by Asad Umar, the Minister for Planning.

Abbreviation :

• [1] – Drug Regulatory Authority of Pakistan 
• [2] – National Command and Operations Centre

3. Caplin Steriles enters into a partnership with JAMP Pharma to produce injectables for the Canadian market :

On 18 January 2021, Caplin Point announced the partnership of its subsidiary, Caplin Steriles, with JAMP Pharma. This collaboration was aimed to produce six injectables that are to be filed in Canada. As per reports, some of these injectables have already been filed in the USA[1].

The Chairman of Caplin Point Laboratories expressed his pleasure over this collaboration. He hoped to add more products in due course. He further added that the company has been proactive in expanding its market areas and targeting Canada as part of this approach.

Caplin Steriles Ltd is a sterile product manufacturing company approved by both the USFDA[2] and the EU – GMP [3]. The company has filed over 19 ANDA[4] In the US alone and currently possesses 11 FDA approvals at hand.

JAMP Pharma is also pleased with this collaboration and has expressed its intent to work with the company in the coming years.

Abbreviation :

• [1] – United States of America
• [2] – United States Food and Drug Administration
• [3] – European Union – Good Manufacturing Practices
• [4] – Abbreviated New Drug Application

4. Sinopharm’s COVID – 19 vaccine gets approved for emergency use in Pakistan :

On 15 January 2021, DRAP[1] granted emergency approval to use the COVID – 19 vaccine manufactured by Oxford – AstraZeneca. Following this, the regulatory body granted emergency use approval for the vaccine manufactured by the Chinese National Pharma group, Sinopharm. This was authorized on 18 January 2021.

The Registration Board of the regulatory body conducted a meeting on 18 January 2021. A spokesperson for the regulatory body stated that the EUA[2] of the vaccine was decided upon at this meeting. He further claimed that both the vaccines have been evaluated for their safety and granted EUA with certain conditions only. Adding on, he mentioned that the authorization would be reviewed quarterly. This review will be based on the data regarding the vaccines’ safety, efficacy, and quality.

The Beijing Institute of Biological Products developed this latest vaccine. It showed a 79.3 percent efficacy in the last – stage trials. The Chinese health regulators granted conditional approval of this vaccine in December 2020 for use in China. The two-dose effectiveness of this inactive vaccine is yet to be ascertained.

On 30 December 2020, the Pakistani government decided to procure 1.1 million doses of this vaccine. It further announced that around 500,000 health care workers would be given two doses, each with a margin spoilage of only 10 percent.

This vaccine can be stored at 2 to 8 degrees Celsius and has already been approved in the UAE[3] and Bahrain. 

The Phase-I clinical trial of this vaccine that was conducted in Karachi has reached the final stages with only 10 volunteers left out. This trial was carried out on 150 healthy volunteers at ICCBS[4] in collaboration with Indus Hospital.   

Another official has expressed his concern as he feels that the chances of getting the Oxford – AstraZeneca vaccine are bleak. He opined that this was due to India buying the research and manufacturing the vaccine. He further added that with India prioritizing its own population, the only chance of getting the vaccine was through Covax.

Covax is an alliance set up by the GAVI[5], CEPI[6], and WHO[7] in April 2020. This alliance pledged to provide free vaccines to around 20 percent of the population of around 190 countries. It is being speculated that the first consignment will be received by the start of the second quarter of 2021.

Abbreviation :

• [1] – Drug Regulatory Authority of Pakistan
• [2] – Emergency Use Approval 
• [3] – United Arab Emirates
• [4] – International Centre for Chemical and Biological Sciences
• [5] – Global Alliance for Vaccines and Immunization
• [6] – Coalition for Epidemic Preparedness Innovations
• [7] – World Health Organization

5. Fosun Pharma in talks with the Chinese government to get emergency approval of BioNTech’s vaccine :

On 19 January 2021, Fosun Pharma began proactively working on getting emergency approval for BioNTech’s vaccine in Hong Kong. For this purpose, it began to communicate with Hong Kong’s regional government closely. 

A local committee of experts has also supported this by claiming that the approval would benefit more than risk. It announced this after reviewing the vaccine’s efficacy, safety, and quality on 19 January 2021.

The regional government had agreed to purchase 7.5 million doses of the mRNA COVID – 19 vaccine from Fosun Pharma on 11 December 2020. This vaccine is called BNT162b2 and was jointly developed by Fosun Pharma and BioNTech. Around 1 million doses of this vaccine are expected to be delivered by the first quarter of 2021. 

The government has also claimed that it plans to begin mass vaccination by February 2021. Hong Kong’s financial secretary believes that the economy will pick up in the second half of 2021.

As per Fosun Pharma, it will produce the vaccines in BioNTech’s factory in Europe. The company launched the phase II clinical trials of this vaccine on 24 November 2020. This was carried out in Taizhou and Lianshui. All the trial participants finished two doses and did not report any serious adverse effects as of 12 January 2021. The company does not plan to conduct phase III trials as the domestic epidemic has already been controlled. This is also because of the lack of a suitable environment for the trial.

The BioNTech vaccine is reported to be the first COVID – 19 vaccine to receive WHO’s[1] emergency approval on 31 December 2020. It has been approved for use in the UK[2], Bahrain, Canada, Saudi Arabia, Mexico, and the US[3].

Abbreviation :

• [1] – World Health Organization
• [2] – United Kingdom
• [3] – United States

Read more

• COVID Vaccination Program in India
• Pharma News February 2021 Updates
• Pharma Trends and News Update: 23 Aug’ 2020

References :

• [1] – The Print – 13 January 2021
• [2] – The Hindu – 17 January 2021
• [3] – Mint – 18 January 2021
• [4] – DAWN – 18 January 2021
• [5] – Global times – 20 January 2021