The Hindu Business Line : Irrational drugs

Even as the law against irrational Fixed Dose Combinations has been around since 1988, precious little has been done to prevent the proliferation of absurd FDCs. The nation is paying the price for belated action, says P. A. FRANCIS.

The pharmaceutical industry has been manufacturing and marketing fixed dose combinations (FDCs), many of them irrational and harmful for the last two decades. Initially not many in number, today they are in several thousands and a large number of them have no therapeutic rationale.

The uncontrolled growth of such combinations in India more often than not has been the brainwave of marketing heads of pharmaceutical companies. Responding to the pressure for newer products, marketing heads of pharma companies used to invent combinations of two or more drugs, often launched without an assessment of their therapeutic benefits.

Medical experts the world over, have expressed serious concern over the marketing of an increasing number of drug combinations by pharmaceutical companies, particularly in developing countries. The basis for this concern lies in the universally accepted practice that a drug combination is technically a new drug entity and that its marketing can be allowed only after its safety and efficacy are adequately established.

While combining two drugs, the efficacy and bioavailability of the two drugs undergo a change on account of the reactions between these chemicals. Therefore, detailed clinical trials and bioavailability studies have to be completed before such products are allowed to be marketed. For serious ailments such as TB and AIDS, patients’ intake of more than one drug at a time for longer treatment period is critical and drug combinations are justified for the sake of patient compliance. Unfortunately, that is not the case with most of the FDCs currently marketed in India.

Arming the law

Since FDCs are considered new drugs, the Union Health Ministry amended the Drugs & Cosmetics Rules in 1988 to address this new development. Rule 122 (E) (c) of the Drugs & Cosmetics Rules, says all new drugs have to be approved by the Drug Controller-General of India (DCGI) for marketing in the country after submission of all relevant pre-clinical and clinical trial data. The amendment thus made it abundantly clear that the state drug authorities have no power to issue product licences for FDCs. Most of the drug control departments in the states and Union Territories in any case do not have the expertise or facilities to assess the merits and demerits of drug combinations.

That amendment was observed more in the breach; state licensing authorities (SLAs) continued to permit FDCs over the years without insisting upon the statutory requirements of pre- clinical and clinical trials.

At the same time, the central drug control administration, the office of DCGI that should have assumed this responsibility and acted to check the problem of irrational combinations once the amendment had armed it with the required powers, did almost nothing. Combinations multiplied in the market.

Using the law

In November 2001, the DCGI for the first time issued a directive to state drug controllers expressly prohibiting them from issuing any more licences for combination drugs; state drug control departments continued to ignore the DCGI order.

In July 2004, the DCGI got tougher; it asked the state drug controllers to withdraw all manufacturing licences issued by them for drug combinations after May 2002. That directive too was ignored.

Nearly two decades after the amendment that armed the DGCI with powers to check FDCs, a meeting of the Drug Consultative Committee composed of MPs, Health ministry and DGCI officials held a meeting in July 2007 and reviewed the problem of irrational combinations.

After the meeting, the DCGI once again issued a directive on August 14 to the state drug controllers asking them to start preparing for the removal of irrational combinations from the market. Most state drug controllers ignored the directive.

At long last

In October, the DGCI moved where states feared to tread. On October 26, the DGCI met state drug controllers and industry representatives the next day in Chandigarh. A list of 294 combinations was prepared and classified into different categories based on their irrationality and absurdity with the help of 100 pharmacologists.

Before meeting industry, the office of the DGCI briefed the state drug controllers about the modus operandi of removing these questionable products from the market. In the meeting with the industry representatives subsequently, the DCGI asked them to stop manufacturing all the 294 drug combinations forthwith.

He also wanted products falling under 144 combinations to be removed from the trade channels. In the case of products under the remaining 150 combinations, the DGCI was willing to allow sales of existing stocks but insisted their production cease. In the meantime, he promised a review of the rationality of these combinations within 40 days.

The sins of delay

The DGCI list of irrational products spans major therapeutic categories such as orthopaedics, anti microbial, gastrointestinal and cardiovascular. In orthopaedics alone, there are more than 360 products marketed by top companies such as Dr Reddy’s, Alkem, Zydus Cadila, Cadila Pharma, Nicholas Piramal, Lupin, Glenmark and others. Most of these combinations are of Chlorzoxazone, paracetamol and Diclofenac sodium or ibuprofen.

In the gastrointestinal category, there are 248 irrational products marketed by the same set of companies and others such as Alembic, Ipca, Emcure, Cipla, Intas, Micro, Unichem and Merck.

In this category, a large number of products are of ofloxacin and tinidazole or metronidazole. There are also 200 anti-microbial products classified as irrational belonging to again the same set of companies along with a number of medium and small enterprises.

Industry leaders have opposed the DCGI’s stand; a joint memorandum of all the major pharma associations to the union ministry of health threw the ball back in the drug authorities’ court. It pointed out that the amendment of the Drugs & Cosmetics Rules in 1988, the State Licensing Authorities were required to obtain NOCs from the DCGI before issuing manufacturing licenses for new FDCs. But, the SLAs ignored this stipulation and continued to grant manufacturing licences for combination products.

Associations are of the view that the office of the DCGI was fully aware of this practice. Some SLAs had even brought the matter to the notice of the successive DCGIs, but they had all ignored the alerts thus tip-toeing around the rule. In short, the memo suggested the office of DCGI is also responsible for the current state of affairs and he should, therefore, give industry sufficient time in this matter.

The last resort

Since the DCGI is not in a mood to listen to them, some of the manufacturers from the south have approached the Madras High Court and obtained a stay against the DCGI move early November. The whole action plan of DCGI is in a fix now. Weeding out irrational drugs from the market can commence only after DCGI vacates the stay. This may take a few days or weeks.

For pharmaceutical units, discontinuation of products under 294 combinations would mean loss of business worth nearly Rs 5,000 crore. It is a business they have built over the years by cultivating physicians and the retail trade. They may not let go that business easily; equally the DCGI is convinced about his stand.

Just how the crying need to clean up this mess of irrational and unsafe products for the patient community and the nation’s image is met, only time will tell.

(The author is editor of ‘Pharma Biz’, a leading industry journal.)

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