What is the national drug policy?

1 a) What is the national drug policy?

The World Health Organization (WHO) defines NDP as “a comprehensive framework in which each component plays an important role in achieving one or more of the general objectives of the policy (access, quality, and rational use)”

b) Give Sixteen principles of the Bangladesh National Drug Policy 1982.

The Sixteen Principles of National Drug Policy 1982:

 1.The combination of antibiotics will be prohibited. The combination of antibiotics with glucocorticoid or other similar active ingredients will be banned. Harmful liquid forms of antibiotics (e.g., tetracycline) will be banned. Tetracycline may hamper bone growth and may cause discoloration of teeth of a child. Combinations of antibiotics have no therapeutic advantage; instead, it promotes more adverse effects.

2. The combination of analgesics will be prohibited. The combination of analgesics with iron, vitamins, or alcohol will also be banned. Analgesic combinations promote adverse events, and their therapeutic value is dubious in nature.

3. Due to the risk of addiction or dependency, any combination form of codeine will not be allowed.

 4. In general, combinations can be allowed if there is absolutely no alternative single drug available for treatment or if no alternative single drug is cost-effective, for the purpose.

5. Certain exceptions will be made in the cases of eye, skin, respiratory and hemorrhoidal preparations, co-trimoxazole, oral rehydration salts, antimalarial, iron-folic, etc., as well as certain vitamin preparations, allowing combinations of more than one active ingredient in one product.

6. Vitamins must be formulated as a particular/individual component products, except for B complex. B12 should always be produced as a single-ingredient injectable product. The combining of Vitamins with any other ingredient such as minerals, glycerophosphate, etc., will also be prohibited. The liquid form of vitamins was prohibited in order to prevent the wastage of resources used to produce liquid vitamins, because it has no beneficial impacts on health.

7. Cough syrups, throat pastilles, gripe water, alkalis, and etc. production will be prohibited due to their questionable scientific efficacy.

8. The sale of tonics, enzyme mixtures/preparations, and alleged recuperative and invigorating products should be discontinued.

9. Me-too drugs will not be allowed. Me-too drugs are those drugs that have the same or almost the same efficacy but have non-significant structural dissimilarity.

10. Medicine with uncertain, petite or no healing and beneficial significance, and to a certain degree, from time to time detrimental, dangerous for human health, and often increases the possibility of misuse, will be debarred and proscribed.

11. All prescription chemicals and galenical preparations, which are included in the latest edition of the British Pharmacopeia or the British Pharmaceutical Codex, will be approved.

12. Considering the favorable risk: benefit ratio; certain medicine, despite known severe adverse effects and the possibility of misapplication, may be manufactured in a small amount for limited and regulated use. These medicines will be prescribed by medical specialists only.

 13. The medicines, which can be produced by national medicine industry, should not be imported in order to protect the medicine industry of Bangladesh.

14. A primary pharmaceutical raw material, which is locally manufactured, will be given protection by disallowing it or its substitute to be imported if sufficient quantity is available in the country.

15. Foreign brands were not allowed to manufacture under authorization in any pharmaceutical industry in Bangladesh if the identical or comparable medicines are existing/manufactured in Bangladesh, as this leads to superfluously high prices and imbursement of royalties.

16. According to the policy, “Third Party Licensing” will not be allowed. Under the third party licensing a company can manufacture and distribute drugs in the market.

 

a)    What are the general objectives of the National Drug Policy?

According to WHO, the General Objectives of a National Drug Policy are to Ensure:

1.       Access: equitable availability and affordability of EMs.

2.       Quality: the quality, safety, and efficacy of all medicines.

3.       Rational use: the promotion of a therapeutically sound and cost-effective method of drugs by health professionals and consumers

 

b) Give an Illustration on the impacts of Bangladesh National Drug Policy 1982

Bangladesh NDP 1982 is an epoch-making event in the history of Bangladesh. Before 1982, there was no NDP in Bangladesh. The medicine market in Bangladesh was filled with unnecessary, harmful, and unsafe medicines before NDP 1982 and multinational companies were controlling the pharmaceutical markets of Bangladesh. Only 14 countries, including Bangladesh, had NDP in 1982. On April 27, 1982, an expert committee was formed. Expert Committee consisted of renowned academicians, regulatory personnel, and health activists. Bangladesh NDP 1982 was highly praised by WHO and other international organizations at that time (15,20). After that, the glory of Bangladesh has increased in relation to the policy.

 

a)    Write down about different types of drug scheduling with significance

There are currently 5 schedules for drugs and poison and their meanings are as follows:

1.       Schedule I: Drugs with no current medical use with high potential for abuse and/or addiction.

Ø  Heroin

Ø  LSD

Ø  Marijuana

Ø  Ecstasy

Ø  Quaaludes

Ø  Bath salts

 

2.       Schedule II: Drugs with some medically acceptable uses, but with high potential for abuse and/or addiction. These drugs can be obtained through prescription.

Ø  Methadone

Ø  Demerol

Ø  Vicodin

Ø  OxyContin

Ø  Fentanyl

Ø  Morphine

Ø  Codeine

 

3.       Schedule III: Drugs with low to moderate potential for abuse and/or addiction, but less dangerous than Schedule I or II. These drugs can be obtained through prescription, but generally are not available over the counter.

 

Ø  Suboxone

Ø  Ketamine

Ø  Anabolic steroids

 

4.       Schedule IV: Drugs with viable medical use and low probability of use or misuse.

Ø  Xanax

Ø  Soma

Ø  Klonopin

Ø  Valium

Ø  Ativan

5.       Schedule V: Drugs with low potential for abuse (lower than Schedule IV).

Ø  Robitussin

Ø  Ezogabine

 

 

a)    Define the following terms according to the narcotic control act 1990- Physician, Distillery, Narcotics, Alcohol, Narcotics-addict.

Significant definitions according to this Act:

1.     Alcohol:

It means spirit and any kind of liquor or wine and includes any liquid containing more than five percent of alcohol

2.     Physician:

Means registered dentist and registered medical practitioner as defined in clause (1) and (m) of Section 2 of Medical and Dental Council Act, 1980 (XVI of 1980) and includes registered veterinary practitioner as defined in Section 2 (g) of Bangladesh Veterinary Practitioner Ordinance 1982 (XXX of 1982).

3.     Distillery:

It means any establishment for the manufacture of alcohol.

4.     Narcotics:

It means any narcotic drugs or psychotropic substances or any other substance mentioned in the First Schedule.

5.     Narcotics-addict:

It means a person physically or mentally dependent on narcotics or a person who habitually takes narcotics.

 

6.     Narcotics Addiction Treatment Centre:

It means a narcotics-addiction treatment center established or so declared under this Act.

 

a)    What are the restrictions on prescription of narcotics.

Ø  Classification of Narcotics:

Ø  Class A

Ø  Class A drugs are considered by Parliament to be the most harmful. This category includes heroin, methadone, cocaine (including crack cocaine), ecstasy, magic mushrooms and ‘crystal meth’.

Ø  Class B

Ø  Class B drugs are considered by Parliament to be less harmful than Class A drugs and include amphetamines, barbiturates, cannabis and dihydrocodeine. Certain Class B drugs are reclassified to Class A if they have been prepared for injection. These include amphetamines, dihydrocodeine and codeine.

Ø  Class C

Ø  Class C drugs are considered by Parliament to be the least harmful of the controlled drugs. These include benzodiazepines, steroids.

 

 

b)    How can a narcotic addict be treated.

Treatment of narcotics addicts:

(1) The Director General may direct the narcotics addicted person by a notice in writing to submit himself for treatment by competent physician or at a narcotics addiction treatment center within seven days from the date of receipt of such notice.

(2) If the person mentioned in the notice issused under sub-section (1) is unable to understand the meaning of the notice, the notice shall be served upon his guardian or custodian and the person upon whom such notice is served.

(3) If the directions given in the notice issued under sub-section (1) or (2) are not complied with within seven days from the date of receipt of the notice, the officer issuing the notice, after expiry of the said period, may apply to the concerned District Magistrate or Chief Metropolitan Magistrate for directing the compulsory treatment of the narcotics addicted person.

(4) On receipt of an application under sub-section (3) the District Magistrate or the Chief Metropolitan magistrate shall direct the narcotics addicted person or his custodian or guardian as the case may be by notice in writing to show cause within seven days from the receipt of such notice, by appearance in person or through a representative, as to why the narcotics addicted person shall not be sent to a particular physician or narcoticsaddiction treatment center for compulsory treatment.

(5) If, on receipt of direction under sub-section (4) the cause is shown within due time, the District Magistrate or the Chief Metropolitan Magistrate, within a period not exceeding fifteen days, may after hearing the narcotics addicted person or his custodian or guardian or his representative as the case may be and the applicant mentioned in subsection (3), by an order direct the compulsory treatment of the narcotics addicted person by the physician or at the narcotics-addiction treatment centre as may be mentioned in the said order or may reject the application.

(6) If, the person to whom notice issued under sub-section (4) has been served, fails to show cause within the stipulated period, then the District Magistrate or the Chief Metropolitan Magistrate after considering the application filed under sub-section (3) shall either order the compulsory treatment of the narcotics addicted person or reject the application.

(7) If the narcotics addicted person does not appear or is not produced within seven days from the service of notice issued under sub-section (5) or (6) before the physician or the narcotics-addiction treatment centre for treatment as mentioned in the order, the officer making the application under sub-section (3) may, if necessary, apply force to produce the narcotics addicted person before the aforesaid physician or to the narcotics-addiction treatment centre for treatment.

(8) The Government shall bear all expenses for any compulsory treatment under this section.

 

a)    Define pharmacist.

Pharmacist means a person who for a fee, salary or other consideration paid to him or to another person on his behalf, prepares, distributes, sells, or serves any prescriptions for, any medicine, drug or pharmaceutical preparation.

 

b)    What are the functions of the Pharmacy council of Bangladesh

1. To approve examinations in pharmacy for the purpose of qualified persons for registration as pharmacists.
2. To prescribe the subjects in which approved examinations will be held.
3. To approve the courses of study and practical training in pharmacy, so as to fill up the purpose of admission to approved examination.
4. To prescribe the conditions and procedure for admission of candidates to an approved examination.
5. Standard of teaching to be maintained by institutions conducting the approved courses of study.
6. To prescribe the equipment and facilities to be made available to the students.
7. To recognize degree or diploma in pharmacy for the purpose of registration as pharmacists.
8. Inspection of institutions which conduct any course of study in pharmacy.
9. To prepare and maintain Registers of pharmacists and apprentices in pharmacy.
10. To register pharmacists and grant certificates of registration etc.
11. To hold examinations for the purpose of registration as pharmacists
12. To do such other acts and things required under this ordinance.

 

What is Essential Drug? Write down the name of at least 20 Essential Drug with their available dosage form in Market.

 

The World Health Organization (WHO) defines essential medicines as drugs that meet the majority of a population's healthcare needs. They should be available in adequate amounts and dosage forms at a price the community can afford.

1	Abacavir (ABC)	Oral Liquid, Tablet
2	Acetazolamide	Tablet
3	Acetylsalicylic acid	Suppository, Tablet
4	Aciclovir	Powder for injection, Tablet
5	Albendazole	Tablet (chewable)
6	Amoxicillin	Capsule or Tablet, Powder for oral liquid, Powder for injection
7	Ampicillin	Powder for Injection
8	Anti-D immunoglobulin (human)	Injection
9	Atropine	Injection, Solution (eye drops)
10	BCG vaccine	Injection
11	Chloroquine	Oral liquid, Tablet
12	Chlorpromazine	Injection, Oral liquid, Tablet
13	Ciprofloxacin	Tablet or powder for suspension
14	Cisplatin	Injection
15	Condoms
16	Cyclophosphamide	Powder for injection, Tablet
17	Dexamethasone	Injection
18	Diazepam	Injection, Tablet, Tablet (scored)
19	Fluconazole	Capsule, Oral liquid
20	Folic acid	Tablet
21	Furosemide	Injection, Tablet
22	Glucose	Injectable solution
23	Griseofulvin	Capsule or Tablet
24	Haloperidol	Injection, Tablet
25	Heparin sodium	Injection
26	Hepatitis B vaccine	Injection
27	Ibuprofen	Tablet
28	Insulin Injection (Soluble)	Injection
29	Isoniazide	Tablet, Tablet (scored)
30	Isoniazide + Ethambutol	Tablet
31	Levodopa + Carbidopa	Tablet

 

8. What is a Trademark? Is there any necessity to use Trademarks in our Pharmaceutical Industry? If it is, then why?

Pharmaceutical trademarks are a type of mark that consumers can use to identify trust worthy goods. Trademarks are used to differentiate goods provided by one company from those manufactured by another and can be a symbol, word, phrase, design, or a combination of  these items. Consumers can use trademarks to tell goods apart so that they're making sure to purchase the exact product that they want.

Important Role of Pharmaceutical Trademarks

Pharmaceutical trademarks are important because they help consumers find their desired products, which builds the reputation of the mark and also encourages the pharmaceutical company to maintain the quality of their goods. Without a strong trademark, it would be impossible for consumers to tell the difference between available products. Pharmaceutical trademarks can also help to reduce medication errors in healthcare settings. In addition, a strong trademark helps people choose the correct medications. Trademarks can also incentivize manufacturers to ensure the safety of their existent drugs and invest in new medications.

Chemical Names and Generic Names

In addition to the pharmaceutical trademark, a drug will have a chemical name and a nonproprietary name which will be used to identify the generic form of the drug. Both international and national naming agencies will use these names.

What is INN (International Nonproprietary Names)

An INN (International Nonproprietary Name) is used to identify every pharmaceutical product. The purpose of this naming convention is identifying a drug's active ingredient and is particularly useful to healthcare providers that must be able to understand a drug's chemical composition before prescribing it to patients.

Since 1953, INNs have been given to products intended for international sale by the World Health Organization (WHO). To help prevent confusion, WHO states that an INN is not eligible for use as a pharmaceutical trademark

 

9. a) Describe the rules and regulations of Drug Export processes.

Drug Export:

a. The export of manufactured drugs in the country will be encouraged and incentives will be provided to boost drug export.

 b. Measures will be taken to eliminate all tariff and non-tariff barriers related to drug export.

c. In case of drug export, as per the demands of the importing countries, registration of desired drugs will be granted. However, registration will not be given to any drug which is deemed to be harmful to human or to any other animal or that are detrimental to the environment declared by World Health Organization and any other internationally recognized organization.

d. Foreign currency limit will be enhanced and sending of adequate drug samples for marketing &promotion of drugs in importing country will be permitted

e. In similar fashion, the permission for exporting of Ayurvedic, Unani, Herbal and Homeopathic drugs and the raw materials will be granted.

b) Write down the short notes on National Control Laboratory-NCL

National Control Laboratory-NCL

a. National Control Laboratory-NCL will play the role of central laboratory for drug testing and analysis. Initiatives will be taken to achieve WHO accreditation for NCL enriched with modern facilities, apposite machineries and skilled human resources.

b. Branches of NCL will be established in all divisions of the country phase wise.

c.Centrally an autonomous Nationalreference laboratory will be established.

d.Specialized, modern laboratories for Unani, Ayurvedic, Herbal, Homeopathic and Biochemic system of drugs will be established.

e.Separate cell will set up in the drug testing laboratory for testing of Unani, Ayurvedic, Herbal, Homeopathic and Biochemic system of drugs.

f.National Control Laboratory will be given responsibility to prepare working standards importing reference standards in order to make reference standard/working standard easily available and cost-effective. These standards could be sold to drug manufacturers as per requirement. In addition, the current practices of granting permission to drug manufacturers to import reference and working standards will be continued.

g. For test and analysis of modern and traditional system of medicines, ,capable public, private and autonomous research organizations will be recognized as reference laboratory of NCL.

h. BCSIR (Bangladesh Council of Scientific and Industrial Research), as capable research organization, will be endorsed for test and analysis of modern and traditional system of medicines and as a reference laboratory.

10. As a Regulatory specialist, how can you control the drug advertising and irrational pricing practice?

Prevention of production, sale & distribution of fake, adulterated, sub standard drugs

a. The selling of fake, adulterated, expired, unregistered, counterfeit and misbranded drugs are punishable offences and due to hindrance to good governance in drug sector; consequently, drug manufacturers, importing organization, wholesale and retail sellers are all accountable. Any person or organization associated with the production, marketing, sale, distribution and storage of such drugs shall be subjected to stringent legal action and the respective license will be revoked by Directorate General of Drug Administration.

b. The existing laws will be amended for awarding exemplary punishment to unauthorized manufacturers and sellers, prescribing physicians and health care establishments of substandard, fake, adulterated and unregistered drugs (Allopathic, Ayurvedic, Unani, Herbal, Homeopathic and Biochemics) and medicines in the name of food supplements.

c. Storage, display of expired medicine in the pharmacy, selling drugs by changing or obscuring the expiry date on package or container will be considered as punishable offences.

d.The existing law will be amended to ensure appropriate compensation of the consumers harmed from the use of substandard, fake, adulterated, smuggled food or drugs

H. Briefly describe about Drug registration process.

Drug registration:

a) Selection of drugs for registration:

1. All drugs that are produced in different dosage forms, imported, distributed or marketed or used have to be registered by licensing authority based on the recommendation of Drug Control Committee (DCC). Regular meetings of the DCC will convene to make faster availability of new life-saving drugs for the public.

 2. The function of Drug Control Committee will be to give opinion/recommend for registration through evaluation of safety, efficacy and usefulness of all applied drugs and medical device for locally manufacture or for importation.With this objective the Drug Control Committee will be constituted with specialists and professionals.

b) Registration Criteria:

1. Registration will be given in accordance with established indication. No new indications for any drugs will be approved without the recommendation of Drug Control Committee.

 2. Approval will not be given to manufacture drugs without appropriate infrastructure and quality assurance management. High-tech drugs or those that required different infrastructure and dedicated facilities for production will not be registered without required manufacturing infrastructure as per GMP guidelines of WHO. It is also mentionable that drugs already registered can be produced by competent pharmaceutical industries subject to re-evaluation.

3. Unless essential for treatment, the registration of combination allopathic drugs will be generally discouraged. The possibility of misuse of Combination Product will be given special consideration. In case of registration of allopathic drugs the reference of approval byUnited States Food and Drug Administration (US-FDA), the Medicines and Health Care Products Regulatory Agency (MHRA), or inclusion in British National Formulary (BNF) has to be pursued. If necessary, the registration of existing combination products will be re-evaluated.

4.Ayurvedic, Unani, Herbal, Homeopathic and Biochemic system of drugs will be registered on the basis of recommendation of Drug Control Committee (DCC). Only drugs included in Unani, Ayurvedic and Homeopathic Formulary/Pharmacopoeia will be considered for registration.

5.Only the 1x potency will be required for registration for mother tincture, crude trituration and 12 bio[1]chemic medicine, but no registration will be required for enhanced potencies of homeopathic and biochemic medicines.

6.As per Homoeopathic Pharmacopoeia it is usable by admixture/ converting with the addition of liquid form of medicine in solid vehicle, e.g., lactose/ globules etc. and solid form of medicine in liquid vehicle e.g., purified water/ alcohol etc. In case of potentized medicine through converting from liquid to solid form or solid to liquid form will not require to be registered.

12 As a Regulatory authority what would be your responsibilities?

National Regulatory System: Development and maintenance of regulatory system ➢ Registration and Marketing Authorization: Authorization for individual products

➢ Pharmacovigilance: Monitoring Safety of Medical Products

➢ Market Surveillance and Control: Continuous monitoring quality, safety and efficacy of marketed products

➢ Licensing Establishment: of the manufacture, import, export, distribution, promotion and advertising of medicines

➢ Regulatory Inspecting: Inspection of manufacturers, importers, wholesalers, Distributors, Storage, depots and dispensers of medicines

➢ Laboratory Access and Testing: Laboratory testing of medical products

➢ Clinical Trial Oversight:Regulation of clinical trial of new molecules

➢ Lot Release of Vaccines: on medicines to professionals and the public