#India- Clinical Trials offer no security to clinical trial participants


Trial and error

Kundan Pandey
Issue Date:

Recent notifications offer no security to clinical trial participants

Trial and errorVICTORIn the past eight years, 2,868 deaths have occurred during clinical drug trials across India. But only 89 have been attributed to such trials and compensation has been paid in 45 cases, said the Union health minister on March 5 in Parliament. Considering the Supreme Court’s recent observation that uncontrolled clinical trials “are causing havoc to human life”, Ghulam Nabi Azad’s speech only highlights the poor state of regulations for clinical drug trials.

To tighten guidelines for conducting these trials, the health minstry had amended the Drugs and Cosmetics Rules by passing three not ifications between January and Febr uary. The notifications specify procedures for compensation and functioning of the ethics committee, which is constituted by an institution conducting the trial.

Health activists say the notifications are rife with loopholes. The first one deals with compensation in case of injury or death during clinical trial but the onus of deciding the injury continues to be with those carrying out the trial. S Srinivasan of All India Drug Action Network says, “The notification does not define injury. How does one  prove that an injury is related to the trial? Who is the appellate body in case the compensation is not satisfactory?” Amar Jesani, editor of Indian Journal of Medical Ethics, says it is important that arbitration boards are created at local and regional levels to arbitrate on the quantum of compensation a provision that was present in the draft but is missing in the notification.

Claiming compensation continues to be difficult. As per the first notification, the Drugs Controller Gen eral of India (DCGI) will be the final authority to determine cause of injury and compensation amo unt. There is a provision that the victim, if not satisfied with the compensation decision, can approach the Centre. How ever, it is not clear which Central body should be approached. In the abs ence of an appellate body, the final auth ority should have been a neutral body, say activists.

The first notification ensures that compensation is received within six months. But what if the pharma company does not agree with DCGI’s decision? If it approaches a lower court, the decision could get prolonged indefinitely.

taleActivists say since the majority of the participants in clinical trials are poor, there should be provision that the aggrieved party can promptly approach the resp ective high court. This will fast track the case.

In view of the complications in obtaining compensation, activists have long been demanding that in case a participant starts showing signs of an adverse effect he or she be immediately paid half of the compensation. Although the draft had met this demand, the final version makes no such mention. Srinivasan says the compensation model needs clarity (see http://www.downtoearth.org.in/content/clinical-trialsillogical-compensat… [1]).

Another sphere where government efforts have fallen short is in defining the role of ethics and expert committees in the third notification. Jesani, who has participated in many ethics committees, informs, “The notification on ethics committees is in response to the criticism that they are not registered with public authorities and there is no supervision over them.” The notification, however, does not satisfy on two counts. First, there is no information on how the Central Drugs Standard Control Organisation, which oversees pharma companies and clinical trials, will manage since it is short of staff and low on funds, says Jesani. Secondly, he says, unless all ethics committees adopt a uniform procedure for monitoring trials, their decisions would become arbitrary. “They also need to be independent of their institution’s interests.” Similarly, the third notification does not define the constitution of the expert committee, which is tasked to recommend quantum of compensation to DCGI in case of death. “On what basis will the expert committee recommend has also not been defined,” says Jesani.


Source URL: http://www.downtoearth.org.in/content/trial-and-error


#India – Govt has no plans for National Health Bill #WTFnews

PIB RElease, March 22, 2013

The Government has no plans to introduce National Health Bill. In order to
provide relief to the common man in the area of healthcare, a countrywide
campaign in the name of “Jan Aushadhi Campaign” has been initiated by the
Department of Pharmaceuticals, in collaboration with the State Governments,
by way of opening up of Jan Aushadhi Generic Stores in the Government
Hosptials to supply of generic medicines through Central Pharma Public
Sector Undertakings, to make available quality generic medicines at
affordable prices to all. So far, 149 Jan Aushadhi Stores have been opened
in different States/UTs in the country as on 28.02.2013.

Further, under the provisions of the Drugs (Prices & Control) Order, 1995
(DPCO, 1995), the prices of 74 bulk drugs listed in its First Schedule and
the formulations containing any of these scheduled drugs are controlled.
National Pharmaceutical Pricing Authority (NPPA) fixes or revises prices of
scheduled drugs/formulations as per the provisions of the DPCO, 1995. In
respect of drugs not covered under DPCO, 1995 i.e. non-scheduled drugs,
manufacturers fix the prices by themselves without seeking the approval of
the Government/NPPA. However, the trend in prices of non-scheduled drugs is
monitored and suitable action is taken by NPPA where price increase is more
than 10% in a period of one year on moving basis.

The National Pharmaceutical Pricing Policy -2012 (NPPP-2012) notified on
07.12.2012 provides all the manufacturers/importers manufacturing /
importing the medicines as specified under National List of Essential
Medicines 2011(NLEM-2011) shall be under the purview of price control. The
objective of NPPP-2012 is to put in place a regulatory framework for
pricing of drugs so as to ensure availability of required medicines
essential medicines” at reasonable prices.

The Government is also providing support to the States under the NRHM for
providing free Generic Drugs in Public health facilities. States have been
encouraged to bring out essentials Drugs lists (EDL) facility wise and
Standard Treatment Guidelines to promote safe and efficacious drug use.

This information was given by Minister of State for Health & Family Welfare
Shri AbuHasem Khan Choudhuryin written reply to a question in the LokSabha


#India- How Pharma Giants Use Litigation To Evade Fines

Big companies overprice medicines and often get away with it by resorting to longwinding court cases
Shonali Ghosal


2013-03-30 , Issue 13 Volume 10

Unaffordable? Pharma companies are yet to pay 90 percent of the fines for overpricing drugs, Photo: AFP

Pharma companies have been fleecing the consumers by overpricing their medicines. As of 31 January, the total amount overcharged by companies stands at a mind-boggling Rs 2,596 crore, according to the National Pharmaceutical Pricing Authority (NPPA). This figure is for the period since 1997 when the regulatory body was set up. On the other hand, the amount recovered by the NPPA stands at a measly Rs 234 crore — just 9 percent of the total.

Cipla tops the list of defaulting companies and owes the regulator fines amounting to Rs 1,684 crore. According to the list of erring companies and the recoveries made from them (available on the NPPA website), the pharma giant figures in 16 different instances of overpricing . Despite sending out demand notices, the regulatory body has failed to get Cipla to pay up even in a single instance.

The second major defaulter is Ranbaxy, which has already paid Rs 30 crore in fines, but still has dues pending of Rs 105 crore.

Under the Drugs (Prices Control) Order (DPCO) of 1995, the NPPA is empowered to regulate prices of medicines that use 74 out of the 500 commonly used bulk drugs (active pharmaceutical ingredients in medicines). These 74 drugs are mentioned in the  National List of Essential Medicines of India. When companies overprice these drugs, the NPPA can recover the overcharged amount in addition to an annual interest of approximately 15 percent as per the Essential Commodities Act.

However, once the company challenges the decisions in court, the case drags on as the DPCO does not allow for out-of- court settlements. One contention commonly raised by companies is that the composition of the medicine they produce and market is different from what is mentioned in the notification.

Companies also argue that they are a small-scale industry and therefore exempt from regulation, or that the stipulated price for the composition was not known at the time they introduced the medicine in the market.

As a result, more than 90 percent of the pending fines remain unpaid and locked up in lengthy litigation.

Though most other companies have either paid or have started paying their fines, Cipla has at least three cases stuck in various high courts and the Supreme Court. Consequently, the penalty for overcharging keeps rising every year with the annual interest adding up. Sources say the Supreme Court has asked for all of Cipla’s cases to be sent to it so they may be disposed together.

Some like Delhi-based RTI activist Afroz Alam Sahil raise questions about the efficacy of the NPPA itself. In response to an RTI petition filed by him last year, the NPPA said it does not have a compiled list of drugs and pharmaceutical companies, and asked him to look up the Directory of Pharmaceuticals Manufacturing Units in India on the Internet. “How do they monitor companies they do not have a record of?” asks Sahil.

Replying to another question in the petition, the NPPA stated that the sampling that was done to check if any drugs were actually being sold at rates higher than their MRP was mostly confined to the Delhi region in 2012. “That allows companies to contest the quality of sampling as their drugs are sold all over the country,” says Sahil. “How can the NPPA care only about drugs sold in and around Delhi?”

Though the Ministry of Chemicals and Fertilisers is set to enforce a price cap on 348 ‘essential medicines’ as opposed to the existing 74 bulk drugs on the essential medicines list, this step can contribute to the reining in of drug prices only if the NPPA is able to recover fines from defaulting companies. Currently, about 1,000 formulations that include the 74 essential bulk drugs are under price control.

Along with the proposed expansion of the list, a new Drugs Prices Control Order would also be in place to directly check the price of specific formulations.

While Ranbaxy did not answer TEHELKA’s queries, saying “the matter is sub judice and we cannot comment”, Cipla has not responded despite several calls and emails over the past two weeks.



German producer of thalidomide issues apology, 50 years on #disability


Born without arms and legs, Lynette Rowe (centre) leaves court in Sydney after winning her case over thalidomide (AFP/Gordon Legal/File)

AFP, LONDON, September 2, 2012
The German firm that made thalidomide has issued its first apology in over 50 years to the thousands born disabled as a result of the drug’s use, but a victims’ charity called for more tangible action. Grunenthal’s chief executive Harald Stock in a speech said his company was “very sorry” for its silence towards the victims of the drug, which was sold to pregnant women as a cure for morning sickness in the 1950s and early 1960s.

An estimated 10,000 children worldwide were born with defects — including missing limbs — after their mothers took thalidomide, which was sold in nearly 50 countries before being pulled from the market in 1961.

In a translated copy of the German text published on Grunenthal’s website, Mr.Stock said he wanted to express his company’s “sincere regrets” and “deep sympathy” to all those affected, “their mothers and their families”.Mr.Stock delivered the speech at the inauguration of a special memorial to thalidomide victims in Stolberg, western Germany, where the company is based.

He said his company was taking steps to help the victims of the drug’s use.“We have learned how important it is that we engage in an open dialogue with those affected and to talk and to listen to them,” he said.

“We have begun to mutually develop and implement projects with them [the victims],to improve their living situation and assist in hardship situations easily and efficiently.” But the apology was rejected as insufficient by the charity Thalidomide Agency U.K., which represents people affected by the drug in Britain. Freddie Astbury, the charity’s head consultant, said the company
needed to “put their money where their mouth is” rather than simply express regret.

Mr. Astbury, who was born in Chester in 1959 without arms or legs after his mother took the drug, said: “If they are serious about admitting they are at fault and regret what happened they need to start helping those of us who were affected financially.”



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