Drug Control Policy Vs Practice:

The NDP has had some success in regulating the drugs market of Bangladesh, but many of the goals of this initiative are yet to be achieved.


Few dreadful information

- In 1992, at least 233 Bangladeshi children died after taking a paracetamol based syrup that was tainted with antifreeze. *
- Investigators found poison in seven brands of fever medication
- In Bangladesh, sampling of 5,000 medicines by the Public Health and Drug Testing Laboratory found that 300 medicines were either counterfeit or of very poor quality. *
- In August 2009, a total of 28 children reportedly died after consuming contaminated medicine.  **
- Instead of Propylene Glycol, a local Pharmaceutical used poisonous Diethylene Glycol which is used in tannery and battery industries

*    International Council of Nurses
** Odhikar Report 2009


Protecting Local Manufacturers

Some Achievements
- Today a total of 807 drug companies involved in the production of various Ayurvedic, Unani and homeopathic – medicines in Bangladesh. Out of the 231 registered allopathic manufacturers, only 170 are currently in operation.
- Domestic manufacturers own 82 percent of the total market share, followed by 13 percent by the locally based multinational corporations. Only the remaining five percent is imported.
- The current market size of the Bangladesh drug industry stands at some USD 500 million – compared with approximately USD 1.2 billion and USD 140 million respectively for India and Pakistan.

Pitfall
- Against these potentially optimistic figures, however, is one that remains alarming
- Bangladesh imports approximately 80 percent of the raw material, costs more than USD 130 million per year.
- Although promoting local production of basic raw materials was a major objective of the NDP, this aspect has seen failure.

To make Essential Drugs available

Achievements (!?!)
- Official documents indicate that 80 per cent of the population has access to affordable essential drugs.

The Fact
- However, on the ground, there is plenty of evidence of a scarcity of essential drugs.
- One study conducted in four district hospitals and one medical college hospital showed that only eight per cent of patients received the prescribed medicines
- In another report, two major hospitals in Dhaka were operating without essential medicines for eight consecutive weeks.

Why it is happening???
Is it  because Bangladesh exports drugs to other countries???
No, the reasons include-
- Budgetary constraints
- Improper distribution and storage of medicines
- Mismanagement and other related factors.
- Theft and pilferage of essential medicine from government hospitals.

Control over Drug prices

The Policy
- In Bangladesh the maximum retail price (MRP) of every essential drug is fixed by the Directorate of Drug Administration (DDA); for all other drugs the DDA endorses the companies' quoted prices.

The practice
- Drug prices are quite high in Bangladesh in comparison to neighboring countries.
- The regulatory authorities have virtually no control over drug prices in Bangladesh.
- Indiscriminate pricing can be observed in all therapeutic classes of drugs. For example, prices of various ciprofloxacin brands range from Taka (Tk) 5 to 14 per unit and The price of dexamethasone eyedrops extends from Tk 24 to 90 per 5ml.

Quality of Drugs

Achievements (!?!)
- A 2005 government report did confirm that the quality of drugs has improved and that the proportion of substandard drugs has fallen to just two percent, compared to 36 percent during the pre-NDP era.
- However, at the same time the national drug-testing authority identified counterfeit medicine making up some six percent of the supply.
- The rate is quite high, considering the large number of available drugs in the market, and that substandard drugs are harmful at any dose.

The Fact
- Only the 20 to 25 top companies produce drugs of standard quality.
- Among non-prescription drugs – anywhere between 27 and 69 percent have been identified as substandard. On the other hand, for lifesaving prescription drugs including antibiotics, as much as 50 to 80 percent have been identified as substandard.
- Interestingly, the country also exports around one percent of its drugs to over 70 countries; these are of standard quality.

Ensure rational use of Drug
What does ‘rational use’ means?
- Prescribing the correct drug in adequate doses for a sufficient duration
- Appropriate to the clinical needs of the patient at the lowest cost.

Factors that affect rational drug use includes
- Lack of drug information
- Inadequate training for health professionals
- Poor communication between patients and doctors
- Slack drug regulation and defective drug supply

Practices
- As little as 13 percent of drugs are sold according to a doctor’s prescription, in addition to the fact that most physicians today prescribe unessential drugs.
- The practice of inappropriate self-medication is high, 30 to 40 percent of the population stating that they do so regularly.
- Drugstore salespersons engage in the illegal recommendation and over-the-counter sale of prescription medicine. According to recent surveys, more than half of the medicine are inappropriately prescribed.
-Though Drug-distribution system is composed of small, independent pharmacies; yet out of the roughly 200,000 such pharmacies, only 76,000 have been listed as registered.
- Most of these are run by unqualified people, including those without formal training.

Strengthening the regulation

Policy Vs Facts
- One of the major objectives of Bangladesh’s drug policy 1982 was to promote local production of both finished drugs and raw materials. In 2005, the NDP was amended and allowed foreign drug manufacturers to operate alone or in joint venture with local companies.
- But a number of experts have warned that the post-2005 drugs policy is no longer pro-people, because it is an exploitation only of drug-export potential, rather than providing drug access to the common people.
- The Directorate of Drug Administration is tasked with monitoring and regulating the activities of all drug companies, it does so with the assistance of less than 50 drug inspectors!!!
- Technical support is even more wanting; currently there are no more than two drug-testing laboratories, and both of these, too, are severely under-resourced.
- The testing laboratories is only able to test around a fifth of available drugs. Inevitably this assures that thousands of untested drugs coming into market and apparently into human bodies.
- The importance of post-marketing surveillance for adverse drug reactions has never gained any understanding.

Concluding Remarks

Looking back over the 27 years of the NDP, there have clearly been some notable advances
- In the production of quality drugs in Bangladesh.
- In the elimination of harmful and unnecessary drugs, provision of essential drugs
- In terms of some control over drug prices.

At the same time, other critical issues have remained unaddressed
- Preventing the spread of counterfeit drugs
- Controlling unethical drug marketing
- Promoting rational drug use
- Increasing the local production of raw materials for pharmaceuticals
- Improving the standards of drug dispensing
- Controlling the standards of alternative medicines.

It is largely due to
- The rapid advancement of the country’s drug sector that the infrastructure needed to prevent the spread of spurious drugs has not been allowed to build up in Bangladesh.
- The local pharmaceutical-industry lobby has grown very strong
- The absence of various other local or international drugs-monitoring and patient-rights groups has left drugs-promotion activities largely uncontrolled. Although unethical drug promotion makes it to the headlines from time to time, the consumer associations of Bangladesh rarely take up the matter.

Until the people and their representatives are able to take responsibility for the oversight of pharmaceuticals away from the drugs companies themselves, Bangladesh’s progressive drugs policy may continue to evolve as more harmful than helpful to the public’s health.

The irony is that the NDP of 1982 strengthened the local industry, which has now begun to act like the much-reviled multinationals – expanding its base at the cost of the masses.