FAQ on the Drugs Act, 2035 (1978)

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1. What is the main objective of the Drugs Act, 2035 (1978)?

The Act aims to regulate the manufacture, sale, distribution, export, import, storage, and consumption of drugs to prevent misuse, ensure safety, efficacy, and quality. It was enacted to protect public health by establishing standards and control mechanisms for pharmaceuticals in Nepal.

2. When did the Drugs Act, 2035 come into effect?

The Act was authenticated and published on 25 October 1978 (2035.7.8 B.S.). Specific sections were brought into force at different times through notices in the Nepal Gazette, with implementation phased across several years to cover all aspects of drug regulation.

3. Who enforces the Drugs Act in Nepal?

The Department of Drug Administration (DDA), established under Section 5 of the Act, is the key regulatory body responsible for implementing the Act’s provisions, including issuing licenses, inspecting facilities, enforcing standards, and initiating legal proceedings.

4. What does the Act define as a “drug”?

A drug is any substance used for diagnosing, curing, treating, or preventing disease in humans, animals, or birds, including any compound that alters bodily structure or functions. This includes insecticides and components used in drug manufacturing.

5. What is the role of the Drugs Advisory Council?

Formed under Section 3, the Drugs Advisory Council advises the Government of Nepal on administrative and policy issues relating to drugs. It helps guide strategic decisions on drug regulation and health policies.

6. What is the function of the Drugs Advisory Committee?

As per Section 4, this Committee provides technical advice to the DDA on research, development, testing, and regulatory controls for drugs. It ensures scientific rigor in drug evaluation and classification.

7. What is the definition of “manufacture” in the Act?

Manufacture includes making, preparing, refining, altering, packing, or labeling a drug. However, it excludes dispensing, packing, or repacking a drug immediately before consumption or sale, focusing only on production-scale activities.

8. How does the Act define “dispensing”?

Dispensing is the process of issuing a drug in a labeled container, compounded for a specific patient’s use based on a prescription. It involves preparing a drug from raw or existing compounds for direct consumption.

9. What is required to establish a drug manufacturing industry in Nepal?

A person must first obtain a recommendation letter from the DDA before seeking government approval. This ensures that the applicant meets prescribed safety and quality standards before beginning production.

10. Is a product license necessary before manufacturing a drug?

Yes, even after establishing the industry, the manufacturer must obtain a product license from the DDA before actual drug production begins. This ensures the drug is vetted for safety and efficacy.

11. Are existing industries required to obtain new licenses under the Act?

Yes. Industries already established before the Act’s implementation must also acquire product licenses under Section 8, ensuring uniform compliance with updated regulatory standards.

12. What is the requirement for drug registration before sale or distribution?

All drugs must be registered with the DDA, and a drug registration certificate must be obtained. This ensures that each drug sold in Nepal meets the required quality and safety benchmarks.

13. How can drugs be imported legally?

Before importing any drug, it must be registered with the DDA, and an import registration license must be obtained. This controls the entry of substandard or harmful drugs into the country.

14. What documents are required for drug export or import?

The importer/exporter must first obtain a recommendation letter from the DDA before applying for licenses under prevailing trade laws, ensuring the drug’s compliance with national regulations.

15. Can anyone sell drugs in Nepal without registration?

No. Individuals or entities must register their name and shop with the DDA and obtain a certificate before engaging in drug sales or distribution. Only registered and certified sellers may operate legally.

16. What is the validity period for drug-related licenses and certificates?

Licenses, recommendation letters, and certificates issued under the Act are valid for two years and must be renewed annually within 35 days of expiry. Delays beyond this attract penalties or cancellation.

17. What happens if the renewal deadline is missed?

A grace period of three months is allowed with an additional 25% fee. If renewal is still not completed, the license, recommendation, or certificate automatically becomes invalid.

18. Are all drugs required to meet a minimum quality standard?

Yes. As per Section 12, every drug must be safe for public use, effective in treatment, and maintain prescribed quality standards. Failure to meet these criteria is punishable by law.

19. What if a drug on the market is found to be substandard?

The manufacturer or their agent must recall the drug. The Administrator can also order its return. Substandard drugs may be destroyed, and licenses can be suspended or revoked.

20. Is compensation provided if a harmful drug causes injury or death?

Yes. The manufacturer must compensate the affected person or the deceased’s successor as prescribed under Section 15, ensuring accountability for public harm.

21. Are drugs categorized under this Act?

Yes. The DDA can classify drugs into categories or subcategories in section 17 , including those requiring prescriptions. This helps control the sale of potentially harmful drugs.

22. Can any seller sell prescription drugs?

No. Prescription drugs must be sold by pharmacists, pharmacy assistants, or professional persons. Sellers without such qualifications may only sell non-restricted drugs in limited quantities.

23. Who qualifies as a “pharmacist and Assistant Pharmacist ” under this Act?

A pharmacist is someone with a degree in Bachelor in pharmacy with registered in Nepal pharmacy council. A Assistant pharmacist is someone with a degree in Diploma in pharmacy with registered in Nepal pharmacy council.

24. What constitutes drug misuse or abuse under this Act?

Using drugs without prescriptions, selling without authorization, or violating drug classification laws is deemed abuse or misuse. This is a punishable offense.

25. Are there any restrictions on drug advertising?

Yes. False or misleading advertisements about a drug’s use or benefits are prohibited. Advertising requires prior approval and licensing from the DDA.

26. Can Inspectors search drug facilities?

Yes. Inspectors have full authority to inspect, search, and seize drugs from manufacturers, sellers, or transporters if they suspect non-compliance with the Act.

27. What powers do Inspectors hold during inspection?

They can seal premises, confiscate drugs, order a stop to activities, and send samples for analysis. Their actions must be reported to the Administrator within three days.

28. What if a seized drug is found to be safe?

If the drug meets standards but the handler violated regulations, the Administrator can seize the drug, control its movement, or suspend licenses for up to six months.

29. Can a person challenge a suspension or cancellation order?

Yes. An appeal can be filed with the Secretary at the Ministry of Health within 35 days. The decision must be made within three months.

30. What qualifications are required to be a drug Inspector?

Inspectors must have at least a pharmacy degree or equivalent qualifications with relevant experience. Analysts must have a degree in pharmacy or chemistry and experience in drug testing.

31. What happens to drug samples taken by Inspectors?

Samples are sent to certified lab or Nepal Pharmaceutical Laboratory for testing. Results are submitted to the Administrator for necessary action, including drug recall or license cancellation.

32. Can the government ban certain drugs?

Yes. The Government of Nepal may prohibit the manufacture, sale, or use of any drug via official notice if it’s deemed harmful or unnecessary.

33. Is there any pricing control on drugs?

Yes. The DDA can fix drug prices with Government approval. Once set, prices must be published in the Nepal Gazette and adhered to.

34. What are the rules for prescriptions?

Drugs categorized for prescription use must be prescribed by registered doctors by Nepal medical Council . The rules ensure safe administration and tracking.

35. Can anyone manufacture or store drugs without professionals?

No. Proper human resources, including pharmacists or recognized personnel, must be in place before starting drug manufacture, sale, or storage.

36. Is adulteration of drugs punishable?

Absolutely. Adulterating drugs to alter efficacy or safety, or selling them knowingly, is a serious criminal offense under this Act.

37. Can expired drugs be sold or used?

No. The sale or distribution of expired drugs is strictly prohibited. Violators face penalties ranging from fines to imprisonment.

38. Are there rules for clinical trials of new drugs?

Yes. Anyone wishing to conduct clinical trials must obtain a license from the DDA. The drug must be tested in authorized hospitals or clinics with patient consent.

39. What must be shown on a drug label?

The label must mention the drug system (e.g., Ayurvedic, Allopathic), possible side effects, and relevant descriptions as prescribed by law.

40. How are narcotic and poisonous drugs regulated?

They must be clearly labeled and securely stored. Sellers must maintain detailed records and attach a doctor’s prescription to every sale.

41. What are the penalties for violating the Act?

Penalties range from fines of up to Rs. 100,000 to life imprisonment, depending on the offense’s severity, including harm caused to consumers.

42. Can imprisonment replace unpaid fines?

Yes. If a fine is not paid, the court may impose imprisonment instead, not exceeding five years unless life imprisonment is already imposed.

43. What law governs drug patent rights in Nepal?

Patent registration and rights related to drugs are governed by prevailing national intellectual property laws, not directly by this Act.

44. Can government delegates enforce this Act?

Yes. The Government of Nepal can delegate administrative powers to designated officials to implement the Act more efficiently.

45. Who files drug-related legal cases?

The Government of Nepal is the plaintiff in cases under this Act. Inspectors conduct investigations and file cases with judicial authorities.

46. What authority does an Inspector have in investigations?

They may arrest suspects, search premises, seize goods or documents, and conduct public inquiries, with support from police if needed.

47. Can suspects be detained during investigation?

Yes, with permission from the judicial authority, suspects may be detained for up to 25 days, especially if there’s strong evidence.

48. Can Inspectors seek legal advice during investigations?

Yes. They can consult government attorneys for case preparation. After filing, the government attorney handles prosecution in court.

49. Are rules framed under the Act?

Yes. The Government may frame Rules to implement and supplement the Act’s provisions, offering detailed operational guidelines.

50. What makes the Drugs Act, 2035 significant for Nepal?

It is Nepal’s foundational pharmaceutical law that ensures drug safety, regulates the pharmaceutical industry, and protects public health through legal enforcement, quality control, and accountability.

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