Tag: pharmaceutical 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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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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Pharma- Malaise may get treatment: unique IDs of drugs soon to check fakes


Usually every problem related to health is called medical malaise, but that is a misnomer.  In fact health care comprises tens of different industries. Collective malaise of all these is conveniently projected as medical malaise, related to doctors. Rest remain invisible, earn money and  doctors are blamed. As doctor is a common universal link that is visible with patient. By an average application of wisdom, it is easy to blame doctors for everything,    that goes wrong with patient.

One such problem is presence of fake medicines.  If patient gets fake or low quality medicines and does not get well or gets side effects, doctor will face harassment. Whereas people involved and industry will be sitting pretty and  make money.

Therefore any such step  to correct Pharma –malaise should be a welcome step for  doctors. Although it will be a complex issue, because of complexity involved in implementation and execution of policies. But recognition and beginning to think of the problem is also an important step.

May be a time to treat Pharma- malaise.

India’s highest advisory body on drugs will discuss a mechanism to end the menace of counterfeit medicines at a meeting on 16 May.

According to the proposal to be discussed at the Drug Technical Advisory Board meeting, consumers will be able to check whether the medicines that they have purchased are genuine by texting a unique code to be printed on the medicine’s package to a number, said two people aware of the matter, both of whom requested anonymity.

The government plans to initially build a data bank of 300 medicine brands and their consumption pattern in various parts of the country.

Drug companies will then be asked to print a unique 14-digit alphanumeric code on the package of the drug. Consumers buying the medicine can then inquire via a text message whether the code—and therefore the medicine—is genuine or not.

Pharma firms may be asked to print a unique 14-digit code on drugs’ packaging; consumers can send a text message to find out if the code is genuine or not

A government survey conducted between 2014 and 2016 had found 3.16% of drug samples it tested to be sub-standard, while 0.02% were spurious

A WHO report in 2017 revealed approximately 10.5% of medicines in low- and middle-income countries including India are sub-standard or fake

 

The unique identification code will help consumers avoid buying fake products. The idea is that within seconds, the person should receive a reply indicating whether the drug is legitimate.

 

Fake medicines lead to drug resistance in humans and cause a significant number of deaths, according to public health experts. A government survey

conducted between 2014 and 2016 to check the proportion of substandard drugs in India had found 3.16% of the samples it tested to be substandard, while 0.02% were spurious.

Significantly, even samples from big drug makers were found to be not of standard quality during the survey carried out through the National Institute of Biologicals, according to regulator Central Drugs Standard Control Organization.

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Glenmark Pharmaceuticals under regulatory scrutiny for alleged misconduct


Glenmark Pharmaceuticals Ltd is under regulatory scrutiny for alleged misconduct in carrying out clinical trials recently in Jaipur.

The Central Drugs Standard Control Organisation (CDSCO) has allegedly found that fake identities were used in clinical trials, as well as evidence of substantial departures from good clinical practice (GCP), in what could be the latest blow for India’s drug-testing industry, which has run into a series of problems with international regulators in recent years.

The alleged misconduct on the part of the company has triggered a tough response from India’s apex drug regulatory authority, which has sent a show cause notice to the company for failing to ensure that clinical trial was conducted in accordance with the Drug and Cosmetics Act, 1940 and Rules 1945, GCP guidelines. The regulatory body has sought an explanation about the alleged irregularities within 10 days. Glenmark has, however, denied any wrongdoing.

The company came under the scanner following reports that several people were deceived into participating in an ongoing trial for pain medication to treat osteoarthritis at a  Multispeciality Hospital in Jaipur. A total of 38 kits were supplied by the company, of which only three were issued to the enrolled patients on April 6. Glenmark has suspended the trials.

CDSCO, which had initiated the inquiry and sent a team from its head office on 22 April to the site, found inadequate and inconsistent patient identification. According to the investigations, the enrolment of subjects was “falsified” and “cannot be relied upon”.

The team also found that out of three patients mentioned in the informed consent form (ICF), two were related to each other and did not visit the hospital in the last six months.

 

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