Drug admin ineffective for poor manpower, lack of testing laboratories

The Drug Administration (DA), the country's drug regulatory authority, is failing to foster and oversee the country's Tk 6,000-crore drug industry due to inadequate workforce, testing laboratories and equipment.
The regulatory body is tasked with monitoring and enforcing the implementation of drug regulations in the country as well as regulating production, pricing, sales, export, import of all sorts of drugs in the country. The DA also supervises the procurement of raw and packaging materials by drug manufacturers.
Although the DA is supposed to have a 214-strong workforce, it is administering the enormous task with only 174 employees as the rest of the positions remain unfilled for a long time.
The DA currently has only 37 drug supervisors to monitor drug markets in 64 districts across the country.
Since 1984, the DA's workload has increased at least 20 times and the industry grew much larger, said sources at the DA adding that despite this fact and the retirement of 30 to 40 of its employees, no step was taken to increase the size of its workforce and no one was recruited in the last eight to ten years.
A DA official seeking anonymity said, "In 2002, we placed a proposal to the government for recruitment of manpower and for turning the administration into Directorate General of Drug Administration to have an effective control over the drug sector. However, the government is yet to take any decision regarding this."
After studying the proposal, the health ministry approved it and a few years ago forwarded it to the establishment ministry where it is still awaiting approval, he added.
Aside from manpower, the activities of the DA also get bogged down due to a lack of necessary infrastructure and facilities -- especially drug testing laboratories in every division. The only two such laboratories under the DA located in Chittagong and Mohakhali remain swamped with testing jobs all year long.
After the director of the DA was replaced last year, stakeholders in the drug industry were hopeful that new initiatives would be taken and reforms would be carried out at the DA for better enforcement of drug regulations.
The hopes are diminishing fast as the DA was able to hold only one routine trimester meeting of Drug Control Committee in 11 months period. The trimester meeting of the committee is supposed to discuss the overall drug situation in the country and recommend necessary measures to stabilise the drug market.
The DA's failure in monitoring the situation is hurting the drug industry and the situation is deteriorating, said a number of drug business owners.
The ineffective regulatory body is failing to remedy the setbacks caused by a number of ill-conceived drug policies of the government, said a high official of a drug raw materials import company.
An import ban was imposed on a number of critical medicines as a few local companies started manufacturing those, the importer said adding that users of the particular medicines are now having difficulties finding the medicines in the market as some of the local manufacturers stopped manufacturing the drugs while the others are not producing enough to meet the demand.
The DA did not take any measure in this regard and it appears that the authorities are unaware of the shortage or the quality of the particular medicines produced locally, he alleged.
A representative from another raw materials import firm alleged, "Corruption is so high in the DA that we have to bribe them every time we need approval for importing raw materials. As a result, this extra payment gets added on the price of the imported raw materials and ultimately on the price of the drugs manufactured with it."
The government's long-standing lack of concern towards the DA left the local market wide open and it has been flooded with unwanted drugs such as multivitamins and other combined drugs, said Prof Muniruddin Ahmed of Department of Clinical Pharmacy and Pharmacology at University of Dhaka.
Dishonest physicians who collect commissions from drug manufacturers usually prescribe these types of medicines to their patients, wasting their money, Prof Ahmed went on saying that the drug industry that has immense potential would be destroyed soon if this situation persists.
According to DA data, the country's pharmaceutical industries this year will export finished drugs to 67 countries and the earnings will surpass Tk 400-crore mark -- a significant growth since 2001 when total earnings from export were only Tk 31.80 crore. In 2007, the figure was Tk 350 crore while Tk 204 crore in the year before.
Pharmaceuticals products will be announced as the product of the year by the government this year, said sources.
The pharmaceutical companies, 167 in total, pay the government Tk 600 crore in value added tax (VAT) and a 25 percent corporate tax for launching a new product.
"Besides VAT, the companies pay tax for importing raw materials, licence fee for every product and manufacturing licence fee for each plant every two years," said Nazmul Hassan, general secretary of Bangladesh Association of Pharmaceutical Industries, adding that despite being a substantial revenue maker for the government, the industry barely receives the cooperation it deserves from the DA.
Currently the DA is not capable of providing the level of support the industry needs and for the sake of the flourishing industry, the administration has to be reformed, he observed.