Pharma news – 25 June

Pharma news – 25 June 2020

India plans to reduce the import of API and other raw materials from China

The military face-off between India and China has put both the countries in a frenzy. To prevent things from escalating downhill, both countries have resorted to talking things out smoothly. But despite this, precautionary measures are being adopted from both sides to ensure economic stability even if things go haywire.

In the wake of this face-off, the Indian government has decided to reduce its import dependence on China. It aims to reduce the import of Active pharmaceutical ingredients (API) and key starting materials for producing medicines and medical equipment.

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Officials believe that this might be done by imposing higher duties on Chinese imports.  Another official has claimed that this notion to reduce Chinese imports applies to all the industries. He further added that this decision was also aimed at securing the drug supply of the country as the Indian pharma is highly dependent on the API from China.

India imports around 53 essential APIs from China. All these are used in the manufacturing of tuberculosis medicines, steroids and even vitamins. Apart from this, raw materials for manufacturing medical equipment like small components and pharma packaging materials like plastic, polymers are also largely imported from China.

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The domestic API manufacturing industry of India is mostly situated in Hyderabad and Ahmedabad. The domestic industries contribute to about 8% to 10% of India’s pharmaceutical market that accounts for around Rs.1.33 lakh crore.

India is currently exploring various options to reduce this dependency on China. It is planning to enhance the local production and also source these ingredients from other countries like Germany, Sweden and Italy.

Around 30-35% of the API is being imported to India from these countries and the rest is taken care of by the Chinese imports. The main reason for this large percentage being covered up by the Chinese products is its cost. The Chinese supplies are approximately 25% to 30% cheaper and so are used for bulk manufacturing. The indigenous manufacturers most often produce complex API and this limits their use in various formulations.

2. Pharma companies decide on the final price of the generic version of Remdesivir India

Hetero Healthcare and Cipla had received the approval for manufacturing Remdesivir in India. Remdesivir is usually administered as an injection and around six vials are needed for treating each Covid-19 patient.

The injectable form of Remdesivir that is produced by Hetero labs is called Covifor. This generic version is priced at Rs.5,400 per 100 mg vial.

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Cipla too has begun production of its brand of Remdesivir called Cipremi. As per the company’s statement, Cipremi would cost at less than Rs.5000 per vial for a 100 mg vial. This is by far the lowest pricing for Remdesivir globally. Sources have revealed that Cipremi would most likely be priced at Rs.4000 per vial.

Other drug forms like Jubilant Pharma, Mylan, Cadila Healthcare and Dr.Reddy’s Laboratories are also prepping up for the launch of their version of Remdesivir. Based on the current reports, a further dip in the prices of their generic versions are expected.

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The government has decided to not take any action on the pricing of this drug. An official has claimed that they are currently observing the entire situation unfold and would take action if needed in the future.

Cipla has signed an agreement with BDR Pharmaceutical Internationals regarding the manufacture of Remdesivir. BDR has also recently transferred the formulation technology and other methods of development to Sovereign Pharma.

Both Hetero and Cipla are gearing up to launch their generic versions this weekend. Hetero labs will deliver the first set of 20,000 vials in two equal lots. The first containing 10,000 vials will be immediately dispatched to Hyderabad, Gujarat, Maharashtra, Delhi and Tamilnadu. The second lot will then be supplied to Kolkata, Indore, Patna, Goa, Ranchi, Cochin and some other parts of India within a week.

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The company officials have claimed that they are taking all necessary measures to ensure that Covifor is accessed by all the public and private health care settings across India. Covifor comes as a 100 mg injectable vial that is administered intravenously under the supervision of a registered medical practitioner.

Glenmark has also been proactive in its approach to ensure the availability of favipiravir across the country within a week’s time. It has already supplied favipiravir to Delhi, Harayana and Himachal as they are geographically close to its manufacturing site in Baddi.

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Sources have also claimed that the price of Cipla would be 30% less than that of Glenmark. However, this statement is yet to be verified.

The favipiravir tablets manufactured by Glenmark are priced at Rs.103 per tablet and is being sold in a pack of 34 tablets. It is also being expected that around 1000 to 2000 patients per day would be prescribed with favipiravir. Many believe that favipiravir would only be used to treat mild patients and not for those who do not show the symptoms of fever.

These prices are however expected to drop as many companies are planning to launch their products in the market in a month.

3. AstraZeneca hopes to secure the USFDA’s approval for its three-drug inhaler

AstraZeneca has designed a three-drug inhaler to prevent flare-ups and death in cases of COPD. On 24 June 2020, the company announced that the ETHOS trial of a triple-drug therapy, Berztri Aerosphere had shown positive results in COPD patients. This therapy was initially called as PT010. The drug firm plans to use this therapy to catch up with its rival Glaxoxmithkline’s Trelegy Ellipta drug.

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When Breztri was compared with standard two-drug inhalers, it was found that the risk of death was reduced by 46%. Apart from this, the recurrence of flare-ups was also reduced and this lied around 13% to 24%.

Breztri had earlier received regulatory approval from China and Japan for treating COPD. This approval was granted based on the studies conducted by the company in 2019. The USFDA[1], however, requested more data to approve this therapy.

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The company is now planning to convince the USFDA with the results of this recent trial. It is expecting to secure the approval and begin marketing in the US market by the second half of 2020.

Chronic obstructive pulmonary (COPD) disease is commonly known as smoker’s lung. It is a deadly condition that has affected more than 380 million people across the globe. Smoking is the primary cause of COPD. But occupational hazards like chemical fumes and air pollution are also capable of causing COPD.

ETHOS trial is a randomized, double-blinded, multi-center and parallel-group trial that is carried out for 52 weeks. It aims at evaluating the safety and efficacy of Breztri Aerosphere in symptomatic patients with moderate to severe COPD. These patients are chosen based on the history of flare-ups in the previous year of the study.

Abbreviation:

1. United States Food and Drug Administration

References:

[1]China pharmaceutical imports to face curbs– Times of India – 23 June 2020

[2]A pricing war– Business Standard – 24 June 2020

[3]Astrazeneca eyes three drug inhaler opportunity– Reuters – 24 June 2020

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