Regulation of medicines: Herbalists fear for their livelihoods in wake of new laws

Drug Regulatory Authority of Pakistan wants herbalists to conform to international standards

KARACHI: Hakims, herbalists, homeopaths and manufacturers of various alternative medicines have voiced serious concern over the Drug Regulatory Authority of Pakistan's (DRAP) directives to regulate their medicines according to the laws designed for allopathic medicines. 

Pakistan Tibbi Conference senior vice-president Hakim Dr Zahid Ashraf told The Express Tribune that they fully supported the formulation of laws for Tibb-e-Unani (Eastern system of medicine) and homeopathy. "We have been requesting the government for the last 30 years to formulate laws for traditional medicines," said Dr Ashraf. "We prepared nine drafts that were presented in the National Assembly, but could not be passed into laws."



Pakistan Tibbi Pharmaceutical Manufacturers Association (PTPMA) secretary for South zone, Muhammad Abdul Qayyum explained why. "We cannot evaluate herbal medicines on the parameters of allopathic pharmaceutical drugs." In response to a question regarding the concerns of the conventional medical industry, Qayyum said that all the senior officials of the DRAP were pharmacists. In their academic pursuits, they have never studied anything about Tibb-e-Unani system of medicine. "How can they prepare rules for a system they know nothing about?" he questioned.

"The testing methods for herbal medicines, which usually contain raw materials of plants, animals and minerals, are extremely complex," Qayyum explained. "The DRAP has asked us to test Tibb-e-Unani medicines by European, British or US pharmacopoeia methods. More importantly, the herbs available in Pakistan are different from the ones available in Europe or USA." He added that the Tibb-e-Unani formulations found no mention in European or US pharmacopoeias. "In such a scenario, how do they expect us to test our medicines by European standards?"

Moreover, DRAP requires Tibb-e-Unani, homeopathic and alternative medicine manufacturers to establish their own laboratories. A small testing laboratory would require an approximate investment of Rs40 to Rs50 million.  "How can a small manufacturer, with an annual turnover of less than Rs5 million, afford to make such a large investment?" he asked. He advised the government to establish a laboratory so that medicines could be tested there.

Herbalists believe that DRAP authorities should learn from India, where Ayurvedic and Unani medicines have been regulated for several decades. The effective mechanism has placed Ayurvedic medicines in the global market. Today, India is one of the largest exporters of traditional medicines and related products. DRAP authorities, instead of devising policies to encourage production and export of traditional medicines, are focused on closing down the industry, he lamented.

"It is feared that small manufacturers in the country will not be able to fulfill the requirements of the SRO-412," said Hakeem Mukhtar Barkati, who has been associated with the Pakistan Tibbi Pharmaceutical Manufacturers Council (PTPMC) for the last 17 years and has been running his clinic in Liaquatabad since 1952. "Over 100,000 shopkeepers will be directly affected because of not getting the licence due to unnecessary restrictions," he added.

The DRAP was formulated through an Act that was drafted and presented by Senator Abdul Haseeb Khan in the Senate in 2012. It was not active then, but now we are all set to implement it, said the prominent industrialist, Khan, at a press conference at the Karachi Press Club recently. Thereafter, the DRAP had published advertisements in newspapers, asking all medicines manufacturers to register their products by October 1, 2014.

"The manufacturers of Tibb-e-Unani, homeopathic and alternative medicines are unnecessarily worried as they are only being asked to register their medicines," said the senator. The idea was to register all medicines in order to weed out unethical practices. The deadline has now ended but Senator Khan had no clue how many medicines were registered.

For Qayyum, however, the policies of DRAP were unfavourable for the traditional and herbal medicines industry. "Such policies will mean the end of traditional medicines and their place will be taken over by the multinational pharmaceutical industries," he complained. The herbalists' body has also filed a petition against the DRAP in the Sindh High Court.

Published in The Express Tribune, October 20^th, 2014.