Lupin pharmaceuticals recall Cefdinir for oral suspension from the US market :
Pharma News – 6 August: Lupin Pharmaceuticals Inc., based in Baltimore, USA had initiated a countrywide recall of its antibiotic on 2 July 2020. This generic antibiotic is called Cefdinir for oral suspension USP, 250 mg /5mL. It is packaged in 60 mL bottles.
This generic drug is manufactured in the Mandideep manufacturing unit situated in Madhya Pradesh, India.
Around 35,928 bottles of cefdinir oral suspension are being recalled from the US market. This entire lot was manufactured in the Mandideep manufacturing facility. The unfavourable results in the retention samples called forth this action.
The USFDA has also included this in the latest Enforcement report. As per the report, the recall was due to the out-of-specification (OOS) result observed in the assay test of the retention samples.
This voluntary recall is classified as a Class II recall. This type of recall is initiated if the drug rarely produces serious adverse effects. The drugs recalled under this category usually produce temporary and medically reversible adverse effects.
The Mumbai-based drug form had also recalled around 4,92,858 bottles of Metformin hydrochloride extended-release tablets. Both the 500mg and 1000 mg tablets were recalled. This action was attributed to the presence of NMDA above the acceptable limits in the tablets. NMDA is an impurity that is capable of causing cancer in humans.
- 1. United States of America
- The United States Food and Drug Administration
2. Sun Pharma launches its generic version of Favipiravir at Rs.35/tablet :
Pharma News – 6 August: On 4 August 2020, Sun Pharma announced the launch of Fluguard at Rs.35 per tablet. Fluguard is the generic version of Favipiravir 200 mg. It is used for the treatment of mild to moderate Covid-19 cases in the country.
Favipiravir was developed by Fujifilm Holdings Corp and was sold under the brand name Avigan in Japan. It was primarily used for treating influenza.
Owing to the surge in the number of Covid-19 cases in India, the government had approved Favipiravir for Covid-19 treatment. Currently, Favipiravir is the only oral antiviral drug that is approved to treat mild cases of Covid-19 in India.
The drug firm claimed that the economic price of this generic version would enhance its access across the country. It further added that the stocks will be available in the market by a week. The company stated that it would work intimately with the government and the medical community to ensure the availability of Fluguard to all.
Glenmark, Cipla and Hetero Labs are other pharmaceutical majors that are selling Favipiravir in the Indian market.
3. Zenara Pharma receives DCGI’s approval for the sale of ‘Favizen’ in India:
Pharma News – 6 August: Zenara Pharma is a Hyderabad-based drug firm that is a fully owned subsidiary of Biophore India Pharmaceuticals. This company has received the DCGI’s approval for the sale of its generic version of Favipiravir. Its generic version is called ‘Favizen’ and it will be manufactured in the company’s manufacturing unit situated in Hyderabad.
The drug firm has claimed that it produces its own API and hence does not depend on any import for production.
Clinical trials conducted to evaluate the efficacy of Favipiravir in Covid-19 patients have shown positive results so far. These studies had been performed in Russia and some parts of the Middle East. The advanced stage trials are currently in progress in several parts of the world including India.
Zenara Pharma has started contacting state institutions and hospitals to ensure the easy access of Favizen in the country. The company has also begun the export of Favizen to the Middle East and Latin American countries.
Hetero Labs had also received the DCGI’s approval on 29 July 2020 for selling its version of Favipiravir in India.
Glenmark Pharmaceuticals, Cipla, Brinton Pharma and Jenburkt Pharmaceuticals are other drug firms that have received regulatory approval for the sale of Favipiravir in India.
- 1. Drugs Controller General of India
- 2. Active Pharmaceutical ingredient
4.GlaxoSmithKline receives USFDA’s approval for the sale of BLENREP:
Pharma News – 6 August: On 5 August 2020, the USFDA approved GlaxoSmithKline’s blood cancer drug, BLENREP. This drug is used to treat the common form of blood cancer.
BLENREP or belantamab mafodotin is used for the treatment of relapsed and refractory multiple myeloma in adults. It is especially beneficial in cases where the patients do not respond to treatment with an immunomodulatory agent.
Safety concerns over the use of BLENREP were raised in a USFDA panel earlier. This was due to the deposition of BLENREP on the cornea in the eyes of the patient. Despite this risk, the panel approved the use of BLENREP as the benefits of the treatment outweigh the risks.
A panel of the EMA had also recommended the approval of BLENREP in July 2020.
Johnson & Johnson and Genmab’s Darzalex treatment is the rival of belantamab mafodotin. It is being speculated that the approval of this product will strengthen the growing oncology portfolio of GlaxoSmithKline.
- 1. United States Food and Drug Administration
- 2. European Medicines Agency
5. Center plans to reform the drug policy that protects foreign drugs for 5 years:
Pharma News – 6 August: The Department of Pharmaceuticals and the NPPA have recently been discussing revisiting paragraph 32 of the DPCO of 2013. This paragraph deals with the exemptions provided for the sale of medicines developed by foreign companies in India.
The policy under reform exempts the new foreign patented drugs from price control for 5 years in India. This policy was included in an amendment in January 2019. The requirement about the use of indigenous R&D for the production of drugs was also removed under this amendment. This was also applicable to the orphan drugs used to treat rare medical conditions.
While local drug manufacturers criticize this move, the senior officials at the Department of Pharmaceuticals claim otherwise. The officials see this as an opportunity to ensure the access of world-class medicines to all Indian patients.
The domestic drug manufacturers expressed their discontent by stating that this move went against the ‘Make in India’ policy. They further added that this paved way for unequal treatment and would result in the sale of foreign drugs at exorbitant prices.
Experts claim that this will restrict the production of patented drugs in India. They believe that it would encourage foreign companies to commercialize their products in India. This could be a huge blow to the indigenous manufacturers.
Several incidences of multinationals taking advantage of this policy have occurred in the past. This has resulted in the NPPA facing numerous problems and the current plans to revise it are expected to change this situation.
- 1. National Pharmaceuticals Pricing Authority
- 2. Drugs Price Control Order
- 3. Research and Development
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