PRODUCT RECALL - ISO/PC 240

Sunday, May 8, 2011

Saturday, July 31, 2010

PLI India

Despite the growing trend of product recalls globally, Indian companies don’t have a comprehensive strategy to tackle the threat, with a majority still dependent on the traditional product liability cover, according to insurance experts.

Even as more Indian manufacturers exporting goods to the overseas markets opt for the product recall insurance plan, insurance experts say the time has come for India Inc to look at this policy as a ‘risk management tool’ and not as a mere obligation.

“Given the legal framework in India, there are limited damages slapped by consumers on to the manufacturers,” feels Shashwat Sharma, director at KPMG Advisory Services, adding that “the product has a great future with the consumer market becoming more sensitive to safety standards and regulatory provisions more stringent.”

In India, as it stands, most companies opt for product liability insurance that insures their liability against third party claims and bodily injuries. But they tend to overlook product recall cover that protects them against recall costs, consultancy fees, lab expenses, re-work and replacement costs, plus brand equity loss in case of a defective product.

The business for this product comes from sectors such as auto ancillary, food and beverages, pharma, telecom and electronics. “Majority of this demand is driven by contractual requirements, mostly from contracts of manufacturers with US and European entities,” says Ritesh Kumar, chief executive of HDFC ERGO General Insurance. On the other hand, multinationals have the recall cover built into their global progammes. Some of them seek cover locally to the extent of deductibles under those policies.

Over the last decade, US-based Food and Drug Administration (FDA) has triggered several recalls in the food and pharmaceutical industry as witnessed in the cases of Indian companies, Sun Pharmaceutical and Ranbaxy Laboratories. In recent times, carmaker Maruti Suzuki too faced a similar situation when it had to recall 100,000 A-Star cars for faulty parts.

Incidentally, this was not the first time the four-wheeler manufacturer was in a spot, in the beginning of the millenium the company had recalled 76,000 Omni vans. Earlier, even global biggies such as Honda and Nokia had to recall their products owing to defective parts. Insurance brokers say safety apart, a recall severely hurts a company’s reputation in the market.

“The repercussions are widespread. And that’s where the potential lies for this product,” says Sanjay Kedia, country head of Marsh Insurance Brokers. Even Rajive Kumaraswami, head of risk and reinsurance at ICICI Lombard General Insurance agrees. He says gradually owing to increased awareness, companies are waking up to cover their domestic sales too.

The product recall insurance, which was introduced in the Indian market as an extension under the product liability insurance, has evolved as a standalone product over the years. General insurers say the new recall liabilities arising from pollution and transportation has given rise to the newer comprehensive general liability policy that has practically replaced the traditional model of the product liability cover with extension for recall.

“There is also a demand for loss of stock due to recall. The product contamination cover which has its genesis in the food and beverage industry—chocolates and colas—has also triggered the demand for this cover,” says RK Kaul, chairman and managing director of Oriental Insurance.

Moreover, within this product, general insurance companies are now selling different types of recall covers—namely first party and third party recall. In India, the demand is primarily for the third party recall, as auto components and equipment parts form a major part of the export pool.

The pricing of this product has so far remained stable for the last few years and is a function of various underwriting considerations like the industry type, products territory where products are being sold, turnover of company, limits of liability being purchased. Insurers typically charge about 1-1.5% as premium of the limit of liability.

General insurers expect the rates to increase as globally there has been an increase in the frequency of claims reported on this cover. And since product recall is not an off-the-shelf cover, insurance brokers say if companies can negotiate with general insurance companies they can avail themselves of maximum possible triggers of recall covered under the policy.

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Thursday, July 8, 2010

Infant foods, malpractices in Advertising

nfant and Young Child Nutrition:

Pursuing gross violations of the Infant Milk Substitutes, Feeding Bottles and Infant Foods Act,1992 in the following cases:

Johnson and Johnson for advertising their feeding bottles in 1993
Johnson and Johnson for offering one bottle free for every dozen of feeding bottles sold by the retailers in 1993
Johnson and Johnson for having offered 5% discount on all their products, which included a feeding bottle in a leading departmental stores in Mumbai- 1993
Johnson and Johnson, Lintas, the advertising agency and Shoppers Stop have all tendered a written apology for it. Johnson and Johnson decided to stop manufacture of feeding bottles in India since June 1996.
Nestle for violating the labelling requirements - 1993. While Nestle has modified its labels as Mother’s milk is best for the baby and to start complementary foods after six months of age, the case is still going on in the Supreme Court.
Wockhardt for using the brand name Dexolac for all its baby's health products including infant milk substitutes, and infant foods. The company has tendered a written apology for the same and agreed to discontinue use of the brand name Dexolac for products other than infant milk substitutes and feeding bottles- 1994.
Preventing sponsorship of a Scientific programme by Nestle on 13th October 1996 at Jaslok hospital.
Babuline Pharma pvt, Ltd for advertising Babuline gripe water and displaying a feeding bottle on Alfa cable channel- November 2000
Aarey for promoting its milk with a feeding bottle –March 2001
Star India Ltd for showing a feeding bottle in the advertisement to promote Kaun Banega Crorepati- May 2001.
Eventus Management Pvt. Ltd for using the picture of a feeding bottle in their promotional campaign for ‘Bouncing Babies Mumbai December 2001.
Raptakos Brett and Company Ltd for offering free sample of Lactodex Starter Formula to Doctors in June 2002
Wockhardt Limited for offering free tin of Dexolac Special Formula to doctors and healthworkers.
Mahananda Dairy for depicting a mother feeding her baby with a feeding bottle in their advertisement to promote Mahananda Cow’s milk which was issued in ‘Dainik Lokmat’ a marathi daily-October 2002.

Drugs and Pharmaceuticals:

acash along with the All India Drug Action Network (AIDAN) was successful in its campaign to boycott companies manufacturing harmful combination drugs eg; Chloramphenicol and Streptomycin.

acash brought to the attention of the High Court about indiscriminate promotion of high dose Oestrogen-Progestron combination. acash was successful in getting a stay order passedon the sale of injectable of high dose E.P. combination. The court instructed the Central Government to ban the drug. Initially the tablets were banned followed by the injections on future litigation and intervention by acash.

acash highlighted the fraud perpetrated by Apollo Hospital, Hyderabad by claiming to cure Retinitis Pigmentosa-1993.

The apparent punitive transfer of FDA Commissioner who ordered closure of Glaxo India Ltd for 10 days for non-disposal of sub-standard drugs was challenged by acash in the High Court in 1993.

On the order passed by the court, the company admitted to its mistake and closed the company for the demanded period of ten days.

Legal Cell:

The legal cell set up by acash is the only one of its kind in India. It has provided a ray of hope to the consumers of health services. The cell has helped acash to address and process complaints of medical negligence under the Consumer Protection Act. Our experience shows that the number of people approaching acash has increased four fold. acash receives cases from all over India. So far acashhas processed about 350 cases. Medical negligence has been proved in 79 cases related to surgery, orthopaedics, gynaecology, opthalmology among others. A few of the cases have been settled mutually between the doctors and the patients as an out of court settlement.

Bombay Nursing Homes Regulation Act:

acash was invited by the Directorate General of Health Services, Maharashtra to discuss and deliberate on enforcement of the Clinical Establishment Act. acash had offered certain recommendations to the Act. acash has been included to be a part of the sub-committee to review the definitions and clauses in the proposed Act.

In August 2002, a meeting was again called to review the definitions and clauses of the Act. The sub-committee has offered comprehensive suggestions to the definitions and clauses of the Act. The Government has agreed to include consumer organisations while constituting a ‘Competent Authority’ and an ‘Apex Body’ under the proposed Act.

Tobacco Control :

Constant lobbying by acash with the Government has led to the passing of The Cigarettes and other Tobacco Products (Prevention of advertisement and regulation of trade and commerce, production supply and distribution )Act, 2003.

Public Interest Litigation against Gutkha:

The PIL filed by acash in the larger interest of public health and safety praying for directions/orders to the Union Government to completely ban the production, manufacture, distribution, sale, storage and import of Gutkha and Panmasala has been admitted in the Bombay High Court on 7th January,2004 . In the PIL , acash as an alternative has sought directions and orders to prevent all forms of advertising, promotion and publicity of these harmful products. The petition also seeks to include the warning against Gutkha in the labelling requirements as defined in the Prevention of Food Adulteration Act, 1954.

Advocating for other Public health and safety issues:

acash filed a petition to bring to light the bad maintainence of post-mortem rooms and wrong disposal of dead bodies thereof. The committee appointed by the High Court has made recommendation regarding improvement of post-mortem rooms. The Government has given a one year period to implement the recommendations put forth by the committee.

A study conducted among traffic policemen by the Indian Institution of Sciences prompted acash to file a writ petition in 1999 in the High Court demanding protection and regular monitoring the health of the traffic policemen and regulation of the pollution levels in the city. This has triggered off the landmark judgement insisting on strict PUC certification of the city cabs.

In order to improve the quality of Eye banking in the country, acash filed a petition in the High Court demanding registration of eye banks based on appropriate rules and regulations. Responding to this the Court has directed the State Government to request the concerned central ministry to frame these rules

Source

PATIENTS RIGHTS AND RESPONSIBILITIES

By Dr. Arun Bal, President, ACASH

Health is a subject closer to everybody’s heart. Improvement of one’s health and health of one’s family is a universal aspiration. However health has been always given a low priority status in the nation’s political and social agenda. With the increasing privatization of the health care services in the country, the state is slowly abdicating its responsibility to provide health care to the people. Medical profession contributes to the healthcare to the extent of only 25-30%. Approximately 70% input in the health care is by various sectors like the pharmaceutical industry, hospitals, blood banks etc. This 70% inputs are mostly managed on a commercial basis and therefore patient as a consumer must have certain rights. These rights of a patient as a consumer are more important than the rights of a general consumer because patient usually has very little choice in the treatment.

WHAT ARE PATIENTS RIGHTS?

Patients rights emanate from human rights, constitutional rights, civil rights, consumer rights, codes of ethics of medical and nursing profession. The Indian Constitution bestows certain rights on the citizens. One of them is Right to life. Right to a healthy life is an integral part of the Right to life. WHO’s definition of health includes physical, mental, social, environmental and spiritual aspects of health. Any threat to health care must be considered as denial of the Right to Life. Basic optimal health care is the right of every Indian citizen and it is the responsibility of the state to provide it. The Government in the country has legislated certain laws to protect the citizens. Some of these are, The Drugs and Cosmetics Act, The Medical Council Act and The Consumer Protection Act. The codes of ethics of medical and nursing councils define the duties of the doctors and nurses towards the patients. Thus these duties form the basis of patient’s rights.

These codes of ethics are based on various international codes like The Nuremberg Code, The World Medical Association’s Declaration of Geneva, The World Medical Association’s Declaration of Helsinki, The World Medical Association’s Code of Medical Ethics, Declaration of Tokyo etc. There are certain rights which are for certain special category of patients for e.g.; handicapped /disabled persons. Certain healthy persons also need the cover of patients rights. This category includes women taking various contraceptive pills, healthy persons who undergo vaccination, healthy persons who volunteer for drug trials etc. Thus rights of patients cover a wide spectrum of ill as well as healthy persons.

WHAT PRECAUTIONS SHOULD PATIENTS TAKE TO PROTECT THEIR RIGHTS?

In India there is very little perception about the rights of the patients even amongst the educated persons. Therefore blatant violation of patient’s rights is a routine occurrence. However the situation can be changed if every citizen takes certain precautions while undergoing treatment or while taking drugs/vaccines etc.

1) In case of surgical treatment or invasive investigations and procedures, please make sure that you have understood the nature of the operation. You have the right to know the details of the surgery as well as the details like the expected time of post-operative recovery, expenses likely to be incurred for the surgery, the risks involved, whether there is any non-surgical treatment for your ailment etc.

2) Please make sure the details are understood by you before you sign the consent form. The consent form should be in your mother tongue or the language known to you.

3) At the time of discharge, please make sure that you have been given copies of all the relevant records. As per the decision of the Bombay High Court (Raghunath Raheja v/s Maharashtra Medical Council), every patient or his legal heirs have the right to get the copies of all the case papers on payment of relevant charges.

4) At the time of discharge from the hospital, please make sure that you have received the bills for all the payments made by you. You have the right to get details of the bill like details of drugs administered to you, the details of investigations etc.

5) In case of any treatment, you have the right to ask for a second opinion. However, the second opinion should be taken ONLY with the consent of your physician.

6) If you have any doubts about the treatment you should request the doctor to clarify them. Doctor-Patient communication is of vital importance for the success of any treatment.

7) Please make sure that the doctor has given you all the instructions for the medicines prescribed. You have the right to get all the relevant information about the drugs prescribed to you.

8) In case of invasive/costly investigations, you have the right to know of the alternatives as well as the necessity of the investigations.

9) As a patient, you have the right to take second opinion and/or change the doctor. However, this right should be exercised very judiciously and cautiously. ‘Doctor Shopping is not in the interest of consumers and can cause serious harm due to irregular treatment.

10) Please always preserve all the bills of the purchase of medicines.

11) If you have any complaints about the treatment/investigations/drugs etc., first approach the concerned doctor/hospital. Many times the complaints are due to misunderstanding and failure in communication. These can be resolved at the local level. Many hospitals have their own patient redressal cell. You must first approach such Patient Redressal Cell.

12) If you find that your complaint remains unresolved, then please write down

Your grievance giving all the relevant details in a sequential format and take the advice of a Consumer Organisation in your area before taking any legal action. Please remember that most of the times the complaints can be resolved at the hospital level.

13) In case of substandard drugs, preserve the drug packages with labels/cartons/boxes etc. The complaints about the drugs have to be lodged with the local Food and Drugs Administration.

14) If you are participating in any trial for drugs/therapeutic devise/treatment protocol, you have the right to refuse to participate in the trial. Please make sure that you have understood all the details like duration, risks involved, the expected complications etc. Also make sure that the doctor/hospital conducting the trial has agreed to treat completely any complication arising out of the trial, free of cost. Please make sure that the consent form includes all the details.

15) As a patient you have to expect the medical record pertaining to your illness be treated as confidential. If the details are to be used in a medical conference, please make sure that your consent has been obtained by the doctor/hospital.

16) In case of HIV positive patients, the details can only be disclosed with the patient’s permission. You have to be vigilant to see the HIV reports are not disclosed to the employers/friends/other unauthorized persons.

AVENUES FOR REDRESSAL OF PATIENTS COMPLAINTS

MEDICAL COUNCILS:

Medical Councils are statutory bodies created by an Act of the Parliament/legislature to monitor/govern the medical profession. The council has only ethical jurisdiction. The council cannot give compensation to the complainant or punish the doctors. The only punishment the councils are empowered to give is to cancel the registration either temporarily or permanently. The complainant has to file the complaint with the registrar of the Council and file a specific declaration as per the prescribed format. The council’s executive committee holds the preliminary hearing to find out the prima facie veracity of the complaint. At this meeting only the complainant and the doctor against whom the complaint is filed are allowed to present their sides. Lawyers are not allowed to be present. If the executive committee finds prima facie truth in the complaint, then the full council hears the case. The council meets only twice in a year. Therefore the complaints are not resolved speedily. Also the preliminary hearing is heavily weighed against the complaint who is usually a non medical person. Therefore councils have been very ineffective in resolving the complaints of consumers of healthcare.

CONSUMER COURTS:

The complaints against the medical profession can be filed in the consumer courts. The complaint should be written on a simple paper giving all the details and the compensation demanded. These courts can only give compensation.

Following are the monetary limits of compensation that can be granted by the consumer courts

District Consumer Court

Up to Rs 20 lakh

State Commission

Rs 20 Lakhs to Rs 1 Crore

National Commission

Above Rs 1 crore

All the complaints against the doctor and the hospitals should have an expert certificate/opinion from the doctors of concerned speciality, stating that the complaint is prima facie true and needs further investigations. In the absence off such certificate the complaints against the doctors/hospital are usually not admitted. Therefore the consumers must have all relevant medical records. The expert opinion can be obtained with the help of Consumer Organisation in your area. ACASH along with the Forum for Medical Ethics (FME) has formed an expert panel to help the consumers. It must also be remembered that a fine of Rs 10,000/- can be imposed on the complainant under the Consumer Protection Act if the complaint is found to be vexatious/false. Though the Consumer Protection Act has time limit of 120 days for disposal of cases, in reality, the cases take anywhere between 2 to 3 years for disposal.

CIVIL COURTS:

The redressal of the patient’s complaints through the civil courts is lengthy, time consuming and many times counterproductive. There is a tremendous backlog of cases and the cases take anywhere between 10 to 15 years to complete.

CRIMINAL COURTS:

The redressal of the complaints under criminal law is not very common and recourse to this method should be taken only in exceptional cases.

RIGHTS OF THE PATIENT

Right to considerate and respectful care.

Right to information on diagnosis, treatment and medicines.

Right to obtain all the relevant information about the professionals involved in the patient care.

Right to expect that all the communications and records pertaining to his/her case be treated as confidential

Right to every consideration of his/her privacy concerning his/her medical care programme.

Right to expect prompt treatment in an emergency

Right to refuse to participate in human experimentation, research, project affecting his/her care or treatment.

Right to get copies of medical records

Right to know what hospital rules and regulations apply to him/her as a patient and the facilities obtainable to the patient.

Right to get details of the bill.

Right to seek second opinion about his/her disease, treatment,etc.

RESPONSIBILITIES OF PATIENTS:

To faithfully undergo the agreed therapy.

To follow the doctors instructions diligently.

To take necessary preventive measures in case of infectious diseases as per the doctors instructions.

To be aware that doctors and nurses are also human beings and are amenable to mistakes and lapses.

To make the payment for the treatment, wherever applicable, to the doctors/hospital promptly.

To respect the autonomy of the doctors and nurses.

To treat doctors and nurses with respect.

To be punctual to attend the clinics/hospital/dispensary for the treatment at the given time.

To preserve all the records of one’s illness.

To keep the doctor informed if the patient wants to change the hospital/doctor.

Source

a TALL Story by COMPLAN - Caveat Emptor

MUMBAI: Maharashtra's Food and Drug Administration (FDA) has filed a chargesheet in the Mazgaon metropolitan magistrate's court against health drink Complan's advertising claim that it can add two inches to children's height.

The FDA's chargesheet names seven officials of Heinz India Pvt Ltd in its petition dated May 3, 2010, clearly stating the offence as "an exaggerated advertisement on television channels about food article Complan". The company denied any knowledge about the case.

In an email response, Heinz India officials said, "We are not aware of any such complaint having been filed. We stand by our claim and would defend the same with appropriate research study." But FDA joint commissioner (food) C B Pawar told TOI that a month-long investigation had preceded the filing of the case.

What adds an interesting dimension to the case is the medical movement behind it. The mother who worries about her son being teased "half-ticket" appears to have incensed pediatricians. In fact, the movement began over 30 years ago when paediatrician Dr R K Anand -- also known as India's own Dr Spock for his parenting tips -- took on the MNC's might for suggesting that branded milk products could transform your infant into a "bonnie, bonnie baby".

In the late 1970s, Anand along with like-minded doctors formed the Association for Consumers' Action on Safety & Health (ACASH) and moved the Indian government into formulating the Infant Milk Substitute Act to stop using pictures of babies on tins and packs that could lure mothers to buy the products.

Cut to 2009, when after being flooded with queries from too many mothers about Complan's claims to add two inches, Anand decided to act again. He got in touch with doctors from the Indian Academy of Pediatrics, one of whom fished out the research paper on which Complan has based its ad campaign. A detailed analysis -- on email -- between doctors from various cities followed, thus providing adequate meat for the FDA to act.

"We moved the FDA in November 2009 with our case, stating that there was a clear violation of the Prevention of Food Adulteration Act," said Anand.

ACASH again got in touch with FDA -- through enquiries under the Right to Information -- to find out the action taken on their report. It is only on Wednesday -- months after filing an appeal to the original RTI application -- that they got a copy of the FDA chargesheet.

According to the chargesheet, a copy of which is with TOI, FDA has complained against Heinz India Pvt Ltd in the chief metropolitan court, Mazgaon, for violating the provisions of the Prevention of Food Adulteration Act 1954 and Rules. Seven officials of the company have been named in the chargesheet.

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