Death by medicine

This issue was pitchforked into the limelight in 1961 after the quot;Thalidomide disasterquot;, when Thalidomide was prescribed as a sedative to be used widely by pregnant women to offset morning sickness. What followed was a disaster. Babies born to these women had quot;seal limbsquot; congenital deformity in which babies are born with defective or rudimentary hands and feet.

It was in early 1937 in the US that the first comparative comprehensive drug regulatory law was passedafter the death of 107 people due to the consumption of a drug used in treating common infection. However, this concept still remains utopian in several developing countries.

V.M. Bobade, Joint Commissioner, Headquarters, Food amp; Drugs Administration FDA, Maharashtra, recounts the case of the intake of Comset Forte, an anti-bacterial drug manufactured by Boehringer Mannheim leading to the patients8217; sugar levels dropping drastically. quot;On investigation we found that the drug contained glibenclamide 8212; a hypoglycemic agent used for diabetic patients. We drew samples from different batches of the same drug and found that there was contamination in the raw material used, which indicated lapses in the manufacturing process.quot;

Narendra G. Wagle, a consulting chemical technologist, who is also the Chairman of the Consumer Guidance Society of India, says that contamination can take place in two ways. One, in the manufacturing process when the capsule is filled with the wrong material. The second may occur at thetime of compounding the mixture. quot;This may take place,quot; explains Wagle, quot;if the capsuling machine is not properly cleaned.quot;

Do drug manufacturers really adhere to certain statutory regulations while testing for contamination, before introducing the drug into the market?

Testing for contamination involves two methods. The conventional chemical method tests only for the expected quantity of chemical. Traces of contamination may go undetected. Whereas, in the instrumentation method the composition of the drug is revealed. quot;Most companies are however reluctant to install the instrumentation method since it involves not only huge investments in its installations but also requires highly paid, skilled, technically qualified manpower,quot; says Wagle.

However, Bobade says: quot;In the manufacturing premises never are two drugs consecutively or one after the other formulated or manufactured.quot;

Many pharmaceutical companies including multinationals palm off their manufacturing to smaller establishments in a loanlicensing arrangement, enticed by the lower labour charge involved, without ensuring whether the establishment in question is geared up to meet the quality standards. The standard of hygiene maintained at most small units is appalling.

Though the FDA says that quot;hygienic conditions in small units or large units are always maintained satisfactorily,quot; there have been several incidents to prove it wrong. Justice Lentin commission which looked into the JJ Hospital glycerol tragedy in Mumbai, in which 14 people died after glycerin was intravenously administered to patients, found that the glycerin was adulterated with diethylene glycol 8212; a toxic chemical which converted the drug into industrial grade glycerin.

Apart from the manufacturing problems, there8217;s another hidden danger: side effects. The system of reporting adverse reactions is still in its nascent stage in India. The Adverse Drug Monitoring Cell of the Drugs Monitoring cell of the Drugs Controller General of India DCGI located in Mumbai8217;s KEMHospital records adverse effects of drugs which occur in patients. However, as of today no doctor is legally bound to report any such observations, as there8217;s no law which makes it mandatory for him to do so.

Another problem is the misleading brand names 8212; several allopathic drugs masquerade as Ayurvedic drugs with seemingly innocuous names. Ayurvedic drugs are not stringently controlled by the FDA when compared to allopathic formulations. Though there may be a chapter in the Drugs and Cosmetics Act on Ayurvedic drugs, the standards of quality are not prescribed. But Bobade says that is not the case.

quot;I do not agree that allopathic drugs are sold under misleading Ayurvedic brand names. Brand names are just to give the identity of a product of a particular manufacturer,quot; he says.

Loopholes are abundant though the FDA would not admit them. Despite Schedule J of The Drugs and Cosmetics Rules 1945, listing certain conditions and deformities which cannot be cured by any medicine, there is an abundant supplyof quot;remediesquot; which are increasingly being advertised for improvement of memory, height of children/adults, size of sexual organs, baldness etc.Health tonics and vitamins are another area exploited by pharmaceutical companies all over the world. Dr. Manohar Kamath, a medicolegal consultant and a practising General Practitioner says, quot;A scientific study reveals that in such cases, the drug or product used has a placebo effect8217; 8211; whereby the intake of the placebo a substance has no medicinal benefit for the patient but induces him to believe otherwise.quot;

This brings to the fore the role of the FDA. Are they waiting for complaints to come their way? Is the FDA a watchdog that has lost its bite? The kind of punitive measures taken against a prominent multinational with regard to handling of expired drugs is a case in point. The company was asked to shut down its unit for a mere ten days. Though the laboratory involved in the JJ Hospital glycerol tragedy was blacklisted, nobody was convicted.

The FDA claimsthat their inspectors regularly conduct surprise checks on both manufacturing and retail outlets, to regulate the sale of spurious as well as expired drugs. Dr Arun Bal, President of the Association for Consumers Action on Safety and Health ACASH, who is also a practising diabetician, scoffs at this. quot;It is mandatory under the Indian Pharmacy Act that every chemist shop should have a qualified pharmacist, but is the FDA monitoring this?quot; he says.

As a result, drugs which do not fall under OTC such as Pentazocine, a strong pain killer, along with certain sedatives and hypnotics, which can also become addictive, are being sold freely in the market without prescriptions. quot;In foreign countries, no drug is sold without a prescription 8211; not even ordinary pain killers. A prescription from a doctor is valid only for a period of seven days from the date of issue. It is the reverse in India, you name any drug and it can be made available to you over the counter,quot; says Dr Bal.