1. www.tfda.or.tz 1 CHALLENGES IN REGULATION OF TRADITIONAL AND ALTERNATIVE MEDICINES 24 th March, 2010 MOHSW Conference Room Registration of Herbal Drugs Nditonda B Chukilizo Manager, medicines and Cosmetics Evaluation and Registration Tanzania Food and Drugs Authority P.O.Box 77150 Dar es Salaam, Tanzania Nditonda.chukilizo@tfda.or.tz

2. www.tfda.or.tz 2 Outline of Presentation Introduction Legal position Glossary Registration of herbal drugs Challenges Recommendations

3. www.tfda.or.tz 3 Introduction Prior to July, 2003 traditional medicines were not regulated by the government. The then Pharmaceuticals and Poisons Act, 1978 Section 68 excluded the application of the Act to the possession, sale, manufacture of any substance customarily used in local systems of therapeutics

4. www.tfda.or.tz 4 Herbal medicines/drugs regulated under two different laws. The Traditional and Alternative Medicines Act, 2002 (Act No 23, 2002). The Food, Drugs and Cosmetics Act, 2003 (Act No.1, 2003) Have different definitions under the two laws Legal position

5. www.tfda.or.tz 5 Glossary Act No.1, 2003 defines “Drug'', ''medicine'' or ''pharmaceutical product'' any substance or mixture of substances manufactured, sold or presented for use in- –(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or the symptoms thereof, in man or animal; –(b) restoring, correcting or beneficial modification of organic or mental functions in man or animal; or –(c) articles intended for use as a component of any articles specified in clause (a) or (b) but does not include medical devices or their components, parts or accessories;

6. www.tfda.or.tz 6 Glossary Act No.1, 2003 '‘Herbal drug'' means any labelled preparation in pharmaceutical dosage form that contains as active ingredients one or more substances of natural origin that are derived from plants;

7. www.tfda.or.tz 7 Act No 23, 2002 defines herbal medicines as plant derived material or preparations with the therapeutic or other benefits, which contain either raw or processed ingredients from one or more plants; in some traditions material of organic or animal origin may be present. Traditional medicine remedy includes any substance or mixture of substances produced by drying, extracting, crushing or comminuting, compressing natural substance of a plant or animal or mineral origin or any part of such substances. Glossary

8. www.tfda.or.tz 8 Regulation of herbal medicines/drugs Despite providing for the definition, Act No 23, 2002 neither provides for regulation of herbal medicines nor traditional medicine remedy Act No.1, 2003 provides for the regulation of all kinds medicines. It does not exclude herbal medicines or traditional medicine remedy and thence as far as regulation of medicines is concerned there is no legal lacunae.

9. www.tfda.or.tz 9 Regulation of herbal medicines/drugs The major problem has been the mixing up of herbal medicines and traditional medicine remedy as being interchangeable Traditional medicine remedy should only be herbal medicines used in local systems of therapeutics Local should refer to Tanzanian communities only as it used to be under the defunct Pharmaceutical and poisons Act,1978

10. www.tfda.or.tz 10 Registration of Herbal Drugs Registration is official approval of a medicine after it has been proven to laid down standards of quality, safety and efficacy. Quality, safety and efficacy is established through pre-market evaluation of scientific research and development, manufacturing and testing data compiled in a drug dossier and inspection of manufacturing facilities

11. www.tfda.or.tz 11 Registration of herbal drugs Section 22 of Act No.1, 2003 prohibits the sale of any regulated product unless it is registered, section 52 provides only for registration of drugs and herbal drugs In 2004 TFDA introduced a guidelines for “Guidelines for Application for Registration of Herbal Drugs, 2004” Since then …… Herbal drugs have been registered mainly form India

12. www.tfda.or.tz 12 Registration of herbal drugs Many so called traditional medicines from China are unregistered on the pretext that Act No.1, 2003 is not applicable to them and have actually been obtaining importation permits under Act No 23, 2002 In fact they are not traditional medicines because they are not customarily used in local systems of therapeutics (local –Tanzanian). They are foreign from other cultures

13. www.tfda.or.tz 13 Registration of herbal drugs Even some really traditional medicines such as DFP has also been obtaining approval for sale which is actually market authorization under Act No 23, 2002 This state of affairs has brought confusion in the market and it has made it impossible to regulate herbal medicines Uncontrolled advertisement of herbal medicines

14. www.tfda.or.tz 14 Challenges Dual regulation of herbal medicines Different definitions of herbal medicines and herbal drugs in the two legislations Inadequate trained and experienced personnel in evaluating, prescribing and dispensing of herbal medicines Importation of herbal medicines from foreign cultures under the guise of traditional medicines

15. www.tfda.or.tz 15 Recommendations Bringing the regulation of herbal medicines under TFDA Amending Act No 23, 2002 to remove reference to herbal medicines and traditional medicine remedies Strengthening TFDA by allocating adequate human resources Updating the national drug policy to define roles in accordance with the current environment

16. www.tfda.or.tz 16 Thank you