Regulating manufacture and marketing of homoeopathic medicinal products

The Drug Regulatory Authority of Pakistan has promulgated rules to regulate manufacture and marketing of alternative medicines. A public notice published in newspapers on June 3, 2014 warns that manufacture, import, marketing, supply and stocking of unapproved alternative medicine and health products without authorization of DRAP is an offence under the DRAP Act, 2012 as alternative medicines, including Homeopathy, Unani, Ayurvedic and Chinese medicines, have been brought under the regulatory control of DRAP, through the DRAP Act, 2012.

The analysis exclusively focuses on the likely impact of these rules on homoeopathy and its consumers.

The homeopathic industry has largely remained unregulated. The laissez faire policy of the government over years has led to the flooding of the marketplace with spurious and counterfeit homoeopathic medicines and mushrooming growth of substandard homoeopathic pharmaceutical companies. Most of the drugs manufactured by such companies, particularly the ones claiming to “cure” asthma and rheumatism, have been found to contain non-homoeopathic ingredients. Import of non-homoeopathic drugs under the label of homeopathy is rampant to evade customs duties and taxes.

Successive governments did realize the need for a law to bring homeopathy under a regulatory framework but their lackadaisical efforts from time to time could not move beyond churning out different drafts that could never be made into a law. Over a period of 19 years, from 1992 to 2011, four drafts including those of Homoeopathic Drugs Act 1993 and Alternative and Non-allopathic Drugs Act 2009 were prepared and discarded for unexplained reasons.

As a first step, the DRAP has issued an SRO (No. 412/14), requiring the manufacturers and importers to have themselves and their products enlisted with the DRAP.

The next step will be registration of the Homoeopathic Manufacturing Companies (HMCs), importers and their products. This will involve inspection of the manufacturing units with notices being served to the manufacturers failing to meet the requirements. The proprietary homoeopathic products with claims of efficacy in a certain disease are required to substantiate their claims and provide evidence of safety and effectiveness to qualify for registration with the DRAP. They will also be subject to tests before being released to the market.

It goes without saying that the processes involved in the manufacture of homoeopathic medicines are quite different. Does the DRAP have the capacity and expertise to evaluate homoeopathic products in accordance with the requirements of homeopathic drug manufacturing protocols? In its technical document on the subject, the WHO recommends that the tests to evaluate homeopathic products should be adapted to the particular requirements and special characteristics of homoeopathic manufacturing process.

It is desirable that the DRAP should announce specific guidelines outlining minimum requirements for registration of national manufacturing companies so as to allow them time to shape up and upgrade their manufacturing facilities to the required standards. At the same time, the DRAP should announce a clear policy on how the process of verification of label claims or inside leaflet content is to be carried out. The absence of a policy will give discretionary powers to the officials concerned to decide matters according to their whims. It is desirable that clear guidelines are issued in this regard so that all the cases of verification are dealt with in a just and uniform manner.

Currently, there is no restriction or check on advertising of homoeopathic drug products and manufacturers and importers can and do advertise all type of stuff through newspapers and electronic media under the label of homoeopathic products with misleading claims.  The rules rightly seek to prohibit advertisement of any patent or proprietary homoeopathic product without obtaining approval of its contents from the DRAP. However, there is no provision to oversee promotion campaigns by the HMCs. Currently, homoeopathic products are being marketed in a way as if they were daily-use consumer items. Incentive prizes ranging from PCs to motorcycles and cars and inducements like study tours, Umra packages, recreation excursions, gift schemes, etc., are offered to wholesalers, stockists and homoeopaths to increase sales.   In the frenzied race for grabbing a greater share of the market, even the companies claiming to be ethical in their dealings have not been lagging behind! The DRAP must ensure to curb such unethical practices by amending the rules.

There is also a need to provide for a mechanism to control prices. A just and equitable price control mechanism taking into account the production or landed costs and allowing for a legitimate margin of profit would be in the interest of all the concerned, right from the manufacturer to the end-user. This will ensure availability of homoeopathic medicines at reasonable prices to the consumers and a fair return to the manufacturers and importers. This will also help keep the prices stabilized and within the reach of the common man.

The rules meet the long felt need to regulate in the area of homeopathic pharmaceuticals and, if implemented in the right spirit, will certainly check the menace of spurious and counterfeit homoeopathic medicines, stop proliferation of second-rate HMCs and ensure availability of quality homoeopathic medicines at reasonable prices. Much, however, depends on how earnestly the rules are enforced. Their enforcement in letter and spirit offers a daunting challenge. Whether or not the DRAP will be able to meet the challenge remains to be seen.