Despite superficial resemblances, pharmaceutical products are fundamentally different from FMCGs, cosmetics, and food products. Medicines are meant to be used by those who are compromised by ill health or are at risk of disease. Medicines must deliver on the claims made for them, for far more is at stake here. And safety must be monitored and assured, since the risk of adverse effects is far greater. Unlike consumer goods, the prescription of drugs by doctors, and their use by patients, is based on detailed technical information provided by the company selling the product.

The internal organization of pharmaceutical companies must, therefore, differ from food, cosmetics and FMCG companies. It is obvious that pharmaceutical companies must have sizable departments, streamlined processes and efficient systems to generate, classify, store and disseminate technical and non-technical information that is provided to other groups within the organization and to prescribers and consumers.

These systems and processes must ensure that the claims made for products are accurate and justifiable. Specific individuals within the organization, technically trained and qualified for the job, must be responsible and accountable for monitoring the continued safety of marketed products.

These functions are, typically, the responsibility of the Medical Department - a group of individuals who must be highly trained, qualified, and efficient, but a group that is also often behind-the-scenes, low profile, and, frequently within the Indian pharmaceutical industry, short-staffed, under-resourced, ill-equipped and under-developed.

Assuring Ethical Promotional Practices

One of the basic functions of the Medical Department is quality assurance of promotional material. Are the claims colleagues in Marketing want to make, justifiable? Are the indications for which the drug is being promoted for use approved by the regulators? Are the risks and side effects of the medicine being adequately conveyed to prescribers and users? The Medical Department is entrusted with the responsibility of assuring Management that the answers to these questions are in the affirmative, and that the required systems and processes exist and are being followed to ensure that this continues to be so.

The controls that need to be put in place to provide that assurance often do not exist within the Indian Pharmaceutical Industry. Each item of promotional literature must be systematically checked by a medically qualified individual to see whether there is data to support each of the claims, that risks are conveyed, that information on dosing is provided, and compliance to various other guidelines rules, regulations and laws is maintained. Proof copies of promotional material must be signed by the medical reviewer and archived for later reference. Written operating procedures for this must exist.

Safeguarding Patient Health and Safety

Another crucial responsibility of the Medical Department is to operate a system of adverse event reporting to monitor the safety of marketed products. Again, a majority of pharmaceutical companies in India do not have such a system. The contours of this internationally mandatory system are as follows:

1. Sales staff must be trained to recognize adverse events - defined as any adverse health-related incident occurring while (or after) the patient is on medication, irrespective of whether the medicine is or is not suspected to be the cause.
2. Sales staff must be trained to forward information on adverse events that come to their notice with a specified time frame - usually 24 hours for serious side effects.
3. Sales staff must have available to them, at all times, forms/formats on which such information may be transcribed and faxed to headquarters.
4. A central repository of adverse event information must exist. This must be analyzed periodically to identify recurring adverse events with a particular product and to determine causality.
5. When appropriate, prescribing information must be modified to include new information on risk of adverse events if causality can be determined.

Existence of such a system is essential as an early warning system for quick action in the event of a lapse in quality of a product. It may be argued that putting up an effective adverse event monitoring system must be a prerequisite before companies are permitted license to operate. Perhaps the damage caused by some of the pharmaceuticals-related tragedies we read in the newspapers would be limited if the regulators had the powers and staff strength to enforce and verify operationality of such systems for every company permitted to manufacture and sell pharmaceuticals.

Generating Reliable Clinical Information

Another responsibility of Medical departments is the conduct of clinical trials. Trials are required by law to demonstrate efficacy and safety of a pharmaceutical product prior to marketing. Trials are also required to demonstrate veracity of claims that a company may wish to make while promoting the product. However, trials can only reliably fulfill these objectives if they are appropriately designed, and if the data that is collected can be shown to be authentic. Unfortunately, most "clinical trials" conducted in this country are very poorly designed and there is little monitoring of authenticity of data. Consequently, all too often the results of clinical trials submitted to regulators or used for promotion have little validity, bordering on fraud. Medical departments can hardly be blamed for this. Some companies conducting so-called "clinical trials" do not have a Medical department that can take the blame. In others the department is under-staffed, has received no training in clinical research, is under no pressure from company management or regulatory authorities to improve the quality of trials, and in fact may be under competitive pressures to quickly churn out a report for regulatory or promotional use.

The result is that industry-sponsored "clinical trials" have acquired a bad name in the eyes of practicing physicians and academia, who can scarcely be faulted for their lack of faith in results of industry-sponsored research. But credibility can and does help sell products. Companies that can demonstrate credibility do find it easier to convince customers of the value of their products. And Medical departments within pharmaceutical companies can help restore credibility by repeatedly demonstrating to customers, investigators, opinion leaders, academia, regulators, media, and the public at large, the commitment to scientific principles and propriety. This would require, first that Medical departments attract employ and retain the best available scientific talent. Medical department managers must be trained in all aspects of Pharmaceutical Medicine, not least, in clinical research methodology. Companies that find themselves sponsoring clinical trials - and almost all companies will require, at least, to conduct bioavailability studies - must ensure that they have or are ready to outsource the means to monitor, analyze and report the research. This requires trained clinical study monitors, statisticians, data managers, and clinical research auditors. This also requires the establishment of written operating procedures that are compliant with GCP guidelines. Credit goes to the office of the Drugs Controller General of India for having pushed through the notification of GCP guidelines for clinical research and for commissioning the re-writing of the Schedule Y of the Drugs and Cosmetics Act that will hopefully force recalcitrant sections of the industry into towing the quality line in clinical research. The next step, obviously, is to provide federal regulators with the powers to verify compliance and to have its key staff trained to do so.

Winds of Change

While these core functions of the Medical Department may seen far removed from here-and-now commercial interests, as the industry evolves and globalizes, these functions will be seen to be important to the long-term business interests of the post-consolidation pharmaceutical industry in the country. The regulatory environment is changing, and will ultimately force change within the industry. So will competition, health insurance and the juggernaut of information/business technology. In this essentially knowledge-based industry that currently looks more like a commodity business in India, science and scientific knowledge must find more substantial space. While Medical Departments in some companies already find themselves doing much more than the core functions described above and making more direct commercial contributions to the business, the role of Medical groups within the Indian pharmaceutical industry, in general, is set for major expansion in the coming years.

-- The author is Sr Director, Medical, Pfizer Limited