MEDICINE | Business Upturn

Micro Labs denies allegations, ₹1,000 crore is total expenditure over the years

Yakita Somani — Mon, 22 Aug 2022 08:51:57 +0000

Micro Labs has denied allegations that it gave doctors freebies worth Rs 1,000 crore to promote its anti-inflammatory drug Dolo 650. An NGO informed the Supreme Court on Thursday that the Central Board of Direct Taxes has accused the Bengaluru-based drug firm of distributing Rs 1,000 crore in freebies to doctors in exchange for prescribing its 650 mg tablets.

It told CNBC-TV18 on Monday that the data was gathered over many years across their 14 divisions and 6,000-strong field force. The only freebies distributed by the company were those permitted, such as books, pens, and small mementos, according to the company, which also stated that it is currently cooperating with all investigations.

A Micro Labs spokesperson stated in a statement that some recent media reports falsely and maliciously claimed that the company distributed freebies worth Rs 1,000 crore to promote Dolo 650 in one year. “This is highly misleading and harms the reputation of Micro Labs, the pharmaceutical industry, and doctors.”

Dolo 650, a paracetamol drug, is a fever and pain-relieving medicine that rose to prominence during COVID-19 and is quickly becoming the ‘go-to’ pain-relieving medication in many cases.

This drug’s annual sales were Rs 360 crores, accounting for about 8% of the company’s total sales. Despite raw material costs tripling during COVID, Micro Labs maintained uninterrupted supplies at the government-mandated retail price of less than Rs 2 per tablet, said the spokesperson.

During the COVID-19 period, the Dolo brand, led by the 650 doses, grew to enjoy a 22% share of the total Rs 3,100 crore worth of paracetamol-based drugs sold, which means that 22 out of 100 people chose to buy Dolo among all paracetamol drugs.

In terms of sales for Dolo, despite being subject to price controls or inclusion on the National List of Essential Medicines, the 650 mg dose generated more than Rs 300 crore between March 2021 and February 2022. In some cases, sales were more than 10 to 30 times higher than for comparable drugs.

The Dolo 650 mg brand, which premiered in 1993, was one of the market’s early adopters, with an 80% to 90% market share in the 650 mg category at one point.
Eventually, the market share settled around 50%, rising to 58% during COVID-19.

Surprisingly, the Dolo brand only sees this type of stickiness for the 650 mg strength, despite selling other strengths such as 500 mg.

Dolo 650 mg has also been used to treat other outbreaks such as Chikungunya and dengue fever.

In response to the allegations of freebies, the company stated that it is in discussions with government authorities and has provided relevant documents.

Aurobindo Pharma share rises 4% as it maintains outperform call on stock

Shivya Kumar — Mon, 23 Aug 2021 05:30:49 +0000

The global research firm Aurobindo Pharma outperformed on the stock, with a rise of 4 per cent. The company had a target of Rs 830 per share. While Cronus Pharma stopped allay capital allocation between the two, which became the key component in unlocking the rise of the stakes.

Reports claim that on August 20 Pharma Company announced that a deal of Rs 450 crore to conjure 51 per cent stakes in Cronus Pharma speciality were cancelled.

12 August reports state that the company was enacting upon the merger with Hyderabad-based Cronus, a company associated with the production of generic veterinary pharmaceutical products and inclusive of development and manufacturing of these goods.

The firm had compiled on agreements with the Cronus company for 51 per cent partnership 95,059,963 equity shares of Rs 10 each at a premium of Rs 34.18 per equity share evaluating up to Rs 420 crore.

In a regulatory filing on Friday, Aurobindo Pharma said, “The board of directors in its meeting held today has approved the termination of the aforesaid agreements, and the parties have mutually agreed and terminated the said agreements.”

The stock was elevating at Rs 710.60, up to Rs 29.15, or 4.28 per cent at 09:33 hours. It rose to an intraday high of Rs 725.90 and an intraday low of Rs 703.85.

Indian drugmaker to pay $50mn fine for destroying records before FDA inspection

Devanshu Singla — Wed, 10 Feb 2021 08:12:35 +0000

An Indian drugmaker has agreed to plead guilty and pay a criminal fine of $30 million, and forfeit an additional $20 million for concealing and destroying records prior to a 2013 US Food and Drug Administration’s inspection of its plant, the Department of Justice has announced In a criminal information filed in federal court in the District of Nevada and unsealed on Tuesday, Fresenius Kabi Oncology Limited (FKOL) was charged with violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to Food and Drug Administration’s (FDA) investigators.

“By hiding and deleting manufacturing records, FKOL sought to obstruct the FDA’s regulatory authority and prevent the FDA from doing its job of ensuring the purity and potency of drugs intended for US consumers,” said Acting Assistant Attorney General Brian Boynton of the Justice Department’s Civil Division.

“FKOL’s conduct put vulnerable patients at risk. The Department of Justice will continue to work with FDA to prosecute drug manufacturers who obstruct these inspections,” the statement said.

“Pharmaceutical companies that obstruct FDA inspections jeopardise patient safety,” said US Attorney Nicholas A. Trutanich for the District of Nevada.

According to court documents, FKOL owned and operated a manufacturing plant in Kalyani, West Bengal, that manufactured active pharmaceutical ingredients (APIs) used in various cancer drug products distributed to the United States.

The government alleges that prior to a January 2013 FDA inspection of the Kalyani facility, FKOL plant management directed employees to remove certain records from the premises and delete other records from computers that would have revealed FKOL was manufacturing drug ingredients in contravention of FDA requirements.