Category: pharma industry

The Story of Faulty Johnson & Johnson (J&J) Hip Implant


Govt to track patients with faulty J&J hip implant to ensure compensation

Close to 4,700 people with damaged hip joints in India received the implant before 2010, when it was recalled, of which only 1,080 were tracked and compensated.

   The Union health ministry will establish committees at the Central and state levels to track and compensate patients who received a faulty artificial hip implant that was recalled worldwide by the manufacturer Johnson & Johnson (J&J), in 2010.

Close to 4,700 people with damaged hip joints in India received the implant before 2010, when it was recalled, of which only 1,080 were tracked and compensated. Of them, 275 underwent revision surgeries.

Following complaints from patients, the health ministry set up an 11-member committee on February 7, 2017, to investigate patient complaints of adverse events against J&J’s metal-on-metal Articular Surface Replacement (ASR) hip implant devices — XL Acetabular Hip System and Hip Resurfacing System.

The committee  submitted its report on February 19, 2018. It said specialists must assess cases individually for treatment and compensation of at least Rs 20 lakh.

In November last year, the federal jury in Dallas had ordered J&J and its DePuy Orthopaedics unit to pay $247 million to six patients for not warning patients about the potential risks of the defective design of the metal-on-metal hip implants .

The committee at the state level will be tracking the affected patients. These cases are old and hospitals don’t have data available on them; close to 100 hospitals were approached but there was no data. State governments will be widely advertising the move to see that affected people approach them,” said a senior official, requesting anonymity.

Each case will be physically and clinically assessed by the state government committee to determine the degree of disability and refer to the central government committee to decide on the compensation amount.

In it response J&J said: “DePuy has fully cooperated with the expert committee in their investigation of the ASR matter. However, the Expert Committee Report has not been provided to the company for review to date, so it would be inappropriate for us to comment on it. We would like to reiterate that we have furnished full facts and data available with us to the expert committee.”

Metal on metal implants are rarely used now, say orthopaedic surgeons. “Metal-on-metal hip implants have been largely discontinued because of the associated complications. With other implants, the revision surgery rate would be around 3-5%, but with this particular brand, it was a higher 10-12 percent.

People complain of pain, which is largely due to loosening of the implant and wear and tear of the metal that would cause collection of metal in the body that it would react to. Another  available implant is ceramic cross-linked with plastic polyethylene socket, where head ball is of ceramic and socket of polyethylene.

After years of testing, ASR was imported and marketed in India and in various countries around the world, with all regulatory approval and permissions as were then applicable. After it was on the market, DePuy continued studying and closely watching how the device was performing and in August 2010.  DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National Joint Registry.

It immediately informed the Drugs Controller General of India (DCGI) about the voluntary recall. Since then, we have kept the DCGI informed of all key actions and worked to provide Indian patients and surgeons with the information and support they need, in line with government requirements.”

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Ban imposed on import of Rabies vaccine from tainted Chinese company


The drug controller general of India on Tuesday banned the import of the rabies vaccine from Chinese vaccine manufacturer Changchun Changsheng Life Sciences, which was found to have faked records and ordered to stop production earlier this month by China’s drug controller.

Rabies kills an estimated 20,000 people in India each year, according to the National Rabies Control Programme.
The drug controller general of India on Tuesday banned the import of the rabies vaccine from Chinese vaccine manufacturer Changchun Changsheng Life Sciences, which was found to have faked records and ordered to stop production earlier this month by China’s drug controller.
Officials familiar with the matter said the vaccine is imported by India and procured by both private and government centres that administer it for protection from rabies, which is 100% fatal but can be prevented by vaccination. Rabies kills an estimated 20,000 people in the country each year, according to the National Rabies Control Programme.
“We’re in the process of issuing a show cause notice to the procurer who gets the vaccine for the government .

“The vaccine is being used in India, but we don’t have the exact details of the total number of units imported or where they have been distributed. I have asked my staff to prepare a detailed information report on its import and distribution,” Reddy added. “Once we get the information, we will ask for a recall of the vaccine from market. But till then, there is a blanket ban on its import.”
Rabies is endemic throughout the country, with the exception of Andaman & Nicobar and Lakshadweep. Dogs are responsible for about 97% of human rabies, followed by cats (2%) and monkeys, mongoose and others (1%). According to the city’s civic agencies, each week about 8,000 shots are given to prevent rabies in all government hospitals.
“We get 500 to 700 cases each day, which also includes people there for booster doses. Dog and rat bites are very common. A combination of anti-rabies vaccine, serum and tetanus is injected, depending on the severity of the bite,” said a staff member at Safdarjung Hospital who asked not to be named.
“We usually get products from procurers, who get it from importers. Both Indian- and foreign-made drugs and vaccines, including those from China, are used in the public sector.
On July 24, Chinese president Xi Jinping has ordered a “thorough investigation” into widespread concerns that hundreds of thousands of infants might have been administered fake vaccines produced by one of the country’s largest pharmaceutical firms.
According to official news agency Xinhua, Xi had termed “the illegal production of vaccines by Changchun Changsheng Life Sciences Limited as hideous and appalling”. Reports suggested the company may have supplied ineffective DPT (diphtheria, whooping cough and tetanus) vaccines that were given to babies as young as three months old, and forging data for anti-rabies vaccines.
As outrage among people in China grew over the past week, the company’s leaders apologised in a statement on Sunday, saying they felt “deeply ashamed”, according to the New York Times.

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Viagra & anaesthetic drug sold as herbal alternative medicines


This news in Times of India  is just an tip of the iceberg, the reality  of alternative medicine  industry. Toxic substances being sold at exorbitant prices  labelled as herbal substances can be unmasked only if checked  and controlled strictly.  Gullible masses consume these substances without knowing the right dose or right drugs thinking them as herbal products . Assumptions that they are free from side effects is another myth, that goes unsaid.

MUMBAI: The Aurangabad division of FDA has found sildenafil citrate, commonly known as Viagra, and a short-acting anaesthetic drug in two alternative  medicines meant to increase sexual desire and potency that were randomly tested for quality recently. The worrying finding has prompted the drug regulatory body to issue a statewide circular asking its officials to seize any available stock of these drugs- Power up capsules and Tiger king cream. The containers of both the alternative medicines didn’t mention the allopathic components sildenafil and anaesthetic drug (lignocaine hydrochloride), giving rise to fear of serious health consequences in people who might consume them unknowingly. Viagra, in particular, which is given for erectile dysfunction, is supposed to be taken only when prescribed by a specialist as it can react with other ongoing medications and give rise to life-threatening complications. In July, FDA officials raided the office of Srishti Unani Medicine Agency in Aurangabad and found stocks worth Rs 16,000 that had arrived from Saharanpur district of Uttar Pradesh. Tests revealed each Power up capsule contained 49.45mg of Viagra, while Tiger king cream had a significant amount of lignocaine hydrochloride, though only the herbal components were mentioned in the packing material.

The spurious drugs were manufactured in violation of the Drugs and Cosmetics Act. “We will lodge an FIR against Naman India, the UP-based manufacturer, that has been selling these drugs in the name of herbal medicine to gullible consumers,”, joint commissioner, FDA, Aurangabad. He said the department is yet to establish where these drugs were supposed to be distributed, but there is demand from across the state. It was during a raid in the city sometime in 2015 when the department woke up to rampant adulteration of so-called alternative  medicines with allopathic drugs. An official said it was an “industry worth millions” that clandestinely ran out of Tier-2 and 3 cities or slums in metros. “Under the Act, manufacturing of alternative  drugs needs a licence, but there are no legal provisions for distribution and supply. So monitoring becomes a challenge,” said an FDA official. Medically, doctors say, such rackets are not just about making spurious drugs and making a quick buck but messing with people’s lives. “It’s a menace that has existed for years unchecked. Alternative  practitioners charge exorbitant sums for these  medicines that illegally contain sildenafil, which otherwise costs just Rs 30-40 when sold as an allopathy drug.

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New price index for pharmaceutical products likely


  • Govt plans to introduce a new price index for pharmaceutical products
  • Under the proposed mechanism, the Centre plans to link prices of all medicines with the new pharmaceutical index
  • However, it seems the government’s latest move may also not go well with drug makers

The drug pricing mechanism in the country is likely to be overhauled before the end of this month (India). Among the changes proposed by the government is the move to introduce a new price index for pharmaceutical products that will become the benchmark to determine prices of all medicines sold in the country — even those that are currently outside the drug price control order.

Even now, the government loosely regulates prices of all medicines in public interest. Prices of around 850 essential drugs are capped by the government. The drug price regulator National Pharmaceutical Pricing Authority (NPPA) revises these prices annually based on the wholesale price index (WPI). For all other medicines, companies are allowed to raise prices by no more than 10% in a year.

Under the proposed mechanism, the Centre plans to link prices of all medicines with the new pharmaceutical index. Drug makers will be allowed to revise prices annually only on the basis of movement in the index, sources said.

The proposal is in its final stages and is likely to be notified by the department of pharmaceuticals in June itself. The proposed index will not only replace the WPI for revising prices of scheduled or price-controlled drugs, it will be used to regulate prices of non-scheduled medicines.

The proposal is part of the recommendations made by the government think-tank Niti Aayog for making changes to the Drug Price Control Order, 2013.

Once in place, the new system will change the price movement of all medicines. Under the present price mechanism, only 17% of the over Rs 1 lakh crore domestic pharmaceutical market is under direct government price control. Even by volumes, the government regulates 24% of all medicines sold.

The suggestion to create a new index came in the wake of objections from the pharmaceutical industry to linking of prices with WPI. However, it seems the government’s latest move may also not go well with drug makers.
Experts who believe that linking prices to an index will be better and less discretionary than the present mechanism and may actually result in increase in prices rather than a decrease.

 

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