NECESSITY FOR THE CORRECTION OF AYUSH DRUG REGULATIONS. Dr J. L. N. Sastry M.D.(Ayu.); Ph.D. Head - Health Care Research Dabur India Ltd.

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1 NECESSITY FOR THE CORRECTION OF AYUSH DRUG REGULATIONS Dr J. L. N. Sastry M.D.(Ayu.); Ph.D. Head - Health Care Research Dabur India Ltd.

2 Regulatory aspects related to ASU drugs 1. Drugs & Cosmetics Act & Amendment Rules & Central Council for Indian Medicine Act Central Council for Research in Ayu. Sciences Pharmacopoeial Laboratory for Indian Medicine Ayurvedic Pharmacopoeia Committee Ayurvedic Pharmacopoeia of India - 7 vol. Part A & 3 vol. Part B 2. Ayurvedic Formulary of India - 3 Parts 6. Dept. of IM&H and Dept. of AYUSH / 2003

3 Ayurvedic Drugs or Medicines are regulated by Drugs & Cosmetics Act 1940 [Drugs & Cosmetic Rules, 1945] D&C Act 1940 contain 2 chapters & 1 schedule for AYUSH D&C Rules 1945 contain 5 parts; E 1 & T schedules for AYUSH

D&C Act 1940 Chapter I (Act of 21 of 1962, w.e.f.27.07.1964) Sec 3(a) ASU drug (Act of 13 of 1964, S.2 w.e.f. 15.09.1964) & 3(h) Patent or Proprietary medicines (Act of 68 of 1982, S.3 w.e.f. 01.02.

4 D&C Act 1940 Chapter I (Act of 21 of 1962, w.e.f ) Sec 3(a) ASU drug (Act of 13 of 1964, S.2 w.e.f ) & 3(h) Patent or Proprietary medicines (Act of 68 of 1982, S.3 w.e.f ) Chapter IVA (Act 13 of 1964 w.e.f ) PROVISIONS RELATING TO ASU DRUGS Sec 33C ASUDTAB Sec 33D ASUDCC Sec 33E Misbranded drugs (if not labelled in the prescribed manner etc) Sec 33EE Adulterated drugs Sec 33EEA Spurious drugs Sec 33 EEB Regulation of manufacture for sale of ASU drugs Sec 33EEC Prohibition of manufacture and sale of certain ASU drugs Sec 33EED Power of Central Govt. to prohibit manufacture etc of ASU drugs in public interest Sec 33F Govt Analyst Sec 33G Inspectors (qualifications [as per CCIM act] and powers) Sec 33H Application of provisions of 22, 23, 24 & 25 Sec 33-I Penalty for manufacture, sale etc of ASU drugs in contravention of this chapter Sec 33J Penalty for subsequent offenses Sec 33K Confiscation Sec 33L Application of provisions to Govt. departments Sec 33M Cognizance of offences Sec 33N Power of Central Govt to make rules Sec 33O Power to amend First Schedule (Classical Texts) Schedule I-A Ayurveda & Siddha systems; schedule I-B Unani-Tibbi System

5 D&C Rules 1945 Part IV & VI Import & Registration (homoeopathy medicines included) Part XVI MANUFACTURE FOR SALE OF AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS Rule 151. Manufacturing on more than one set of premises Rule 152. Licensing authorities Rule 153. Application of license to manufacture ASU drugs Rule 153-A. Loan Licence Rule 154. Form of licence to manufacture ASU drugs Rule 154-A. Form of loan licence to manufacture ASU drugs Rule 155. Certificate of renewal Rule 155-A. Certificate of renewal of a loan licence Rule 155-B. Certificate of award of GMP of ASU drugs Rule 156. Duration of licence Rule 156-A. Duration of loan licence Rule 157. Conditions for the grant or renewal of a licence in Form 25-D Rule 158. Conditions of licence Rule 158-A. Conditions of loan licence Rule 159. Cancellation suspension of licence Rule 160. Identification of raw materials Part XVII LABELLING, PACKING & LIMIT OF ALCOHOL IN ASU DRUGS Rule 161. Labelling, packing and limit of alcohol Rule 161-A. Exemption in labelling and packing provisions for export of ASU drugs

6 D&C Rules 1945 continued... Part XVIII GOVT ANALYSTS & INSPECTORS FOR AYURVEDA INCLUDING SIDDHA OR UNANAI DRUGS Rule 162. Duties of inspectors specially authorized to inspect manufacture of ASU drugs Rule 163. Procedure for despatch of sample to Govt. Analysit & its receipt by Govt Analyst PHARMACOPOEIAL LABORATORY FOR INDIAN MEDICINES TO FUNCTION AS CENTRAL DRUGS LABORATORY FOR THE PURPOSE OF TESTING OR ANALYSIS OF AYURVEDA, SIDDHA AND UNANI DRUGS Rule 163A. Functions Rule 163C. Despatch of samples for test or analysis Rule 164D. Recording of condition of seals Rule 163E. Report of result of test or analysis Rule 163F. Fees Rule 163G. Signature on certificates Rule 164. Method for test or analysis to be employed Rule 165. Qualifications Rule 166. Duties of Govt. Analyst Rule 167. Qualifications of Inspectors (Vide: CCIM Act) Part XIX STANDARDS OF ASU DRUGS 168. Standards to be complied with manufacture for sale or for distribution of ASU drugs 169. Permitted excipients Schedule T - GMP norms

Ayurvedic Pharmacopoea of India A. Seven Volumes of API Part I, have been published consisting of 540 monographs on single drugs.

Metals) B. Three Volumes of Ayurvedic Pharmacopoeia Part II, have been published consisting of 101 monographs on formulations.

of monographs I 2007 50 II 2008 51 III 2010 51 Atlas documents: As a supplement to Pharmacopoeial information on drugs, various

7 Ayurvedic Pharmacopoea of India A. Seven Volumes of API Part I, have been published consisting of 540 monographs on single drugs. Volume Year of Publishing No of monographs I II III IV V VI VII (Mineral & Metals) B. Three Volumes of Ayurvedic Pharmacopoeia Part II, have been published consisting of 101 monographs on formulations. Volume Year of Publishing No. of monographs I II III Atlas documents: As a supplement to Pharmacopoeial information on drugs, various Atlases are also being prepared for better comprehension. Following have been published till date: Thin Layer Chromatography Atlas of Pharmacopoeial Drugs (API Part I, Vol. I) Macro & Microscopic Atlas of Pharmacopoeial Drugs (API Part I, Vol. V)

Ayurvedic Formulary of India To bring uniformity among the manufacturers and to follow the same formula of ingredients in the same proportion, two parts of Ayurvedic Formulary of India has been

8 Ayurvedic Formulary of India To bring uniformity among the manufacturers and to follow the same formula of ingredients in the same proportion, two parts of Ayurvedic Formulary of India has been published. In the Ayurvedic Formulary of India Part I and Part II there are 635 Formulations. Both parts are available in English and Hindi separately. AFI Part I (1978)- 444 formulations [vol. 1-] AFI Part II (2000)- 191 formulations [vol. 1-2] Part III with both Hindi & English descriptions (in draft stage)

9 What are the aspects Manufacturer should Comply with?! Rule 153: Application for grant or renewal of license to manufacture ASU drugs - Form 24-D Rule 154: Issue of Licence to manufacture ASU drugs - Form 25-D Rule 154-A: Application for grant or renewal of Loan license for ASU drugs - Form 24-E Issue of Loan licence to manufacture of ASU drugs - Form 25-E Rule 155: The Certificate of Renewal of License in Form 25-D will be issued in Form 26-D Rule 155-A: The Certificate of Renewal of Loan License in Form 25-E will be issued in Form 26-E Rule 155-B: The Certificate of GMP to manufacturers of ASU drugs shall be issued to licensees who comply with Schedule T requirements. Rule 156: Duration of License (3 yrs earlier; 5 yrs at present)

10 Amendments in the Definitions 3.a. ASU Drug Definition:.medicines manufactured exclusively as per books of First Schedule. Amend:. manufactured as per the list of ingredients mentioned in the books of First Schedule by defining a specific batch size, equipment used by the respective manufacturer. 3.h. P&P Medicine Definition:. formulations containing the ingredients of the formulae mentioned in the books of First Schedule.other than parenteral administration. Amend:. formulations made using the herbs / animal sources / minerals-metallic ingredients mentioned in the books of First Schedule. [Note: Suchikabharana fall under parenteral administration under 3(a). Therefore, there is a need to rethink on PE admn.] Definitions for NEW DRUG, INTERMEDIATE & SUBSTITUTE to be introduced

11 Amendments in the Sections Section 33E; 33EE; 33 EEA should not provide immunity for the practitioners of ASU system against the penalty. Section 33G to mention inspectors means who are qualified post graduates from ASU systems and are specially trained and/or certified by the PCIM / PLIM / CCRAS / ICMR or any other reputed pharmacognosy institute. Section 33H restricts the application of testing to ASU drugs only and needs amendment. [check against the standards of manufacturer] Section 33K to be further amended and strengthened to protect the interests of industry in case of false cases (e.g. guggulu is found containing steroids; DT etc for ASU drugs 3(a); References for P&P medicines; notices on specs of non AFI-API formulations etc.,)

12 Amendments in the Rules Rule 155 B (GMP Certificate) should be implemented strictly. QCI certification does not have legal sanctity Rule 157 grant of license should have guidelines and different states have different procedures, panels and there is no uniform system / approach Rule 160 Identification of RM by authentic methods (in PLIM) and not by empirical organoleptic evaluation. No penalty to be imposed before the Central Lab report is obtained Rule 162 to be linked to Section 33 G to define the qualifications of drug inspectors in ASU systems Rule 163A to 167 (PLIM as Central Drug Testing Laboratory for ASU drug testing) the support of industry to be taken for the development of ASU drug standards. This should be different from APC activity.

Rule 168 DRUG STANDARDS 1) Both PLIM (PCIM also) & CCRAS heavily depend on industry for RM samples and FG specifications 2) More then 75 k PP medicines are having self defined standards.

13 Rule 168 DRUG STANDARDS 1) Both PLIM (PCIM also) & CCRAS heavily depend on industry for RM samples and FG specifications 2) More then 75 k PP medicines are having self defined standards. Why not for 750 ASU drugs? 3) Problem with ASU formulations: 1) No clarity of w/v or v/v or w/w in many formulations (Higwashtak churna; Simhanada guggulu; Ghrita & Taila etc) 2) No batch size and wastage mentioned 3) Equipment used by APC / PCIM is not defined 4) Kwathas, Asavarishtas etc to be decided on the basis of TSS (sicne industry is using the modern extraction methods) 5) Specs are made without using excipients, colours, flavours etc. Therefore need revision 4) Premium certification should be on extra standards and not on the basis of QCI certification 5) Why Govt. supplies are not on the basis of quality standards?

14 Amendments in the Schedules First Schedule The list of books pending revision. Therapeutic index of different companies have become Schedule books while books like Madanapala Nighantu, Raja Nighantu are missing. E1 Schedule This be restricted to oral administration and not applicable to topical. T Schedule C-GMP guidelines and certification is needed

15 Amendment.Rule 170 Thanks to Ministry of AYUSH for reconsidering this amendment Approval System would industry be a disaster to the Self discipline is best and MoU with ASCI by AYUSH is a welcome measure The DMR conditions of the notification may be reviewed and finalized for avoidance of advertisement in such condition(s)

16 Questions to be Answered by APC?! Asavarishta dose is fixed at ml against ( ml in Sarngdhara Samhita).?? Dose of Arogyavardhini ( mg in place of 6-8 g); Brihat Vata Chintamani ( mg in place of 360 mg) etc. Gautheria oil etc., have no textual base but allowed!!?? Empirical additions and deductions in quantities done by APC? Chyavanprasha Avaleha contains 500 amla?? or 5 kg amla?? Why yeast (Surabija) not allowed for Asavarishta fermentation. To mimic classical pot fermentation in a fermenter, yeast is needed. The criteria should be alcohol percentage which should be 6-12%. What is the problem in accepting two different botanical sources for one single herb. For example in IP, both Cassia aungustifolia and C. senna are mentioned as Senna.

17 Why change of dosage forms OR variants for classical formulations? It is Consumer need but not Commercial need The public demand is assessed on the basis of a serious market research. No company will introduce Chyawanprash candy / granules without demand No company will introduce Rasnadikvatha tablet / capsule without demand When the ingredients remain same, what is the objection for accepting new dosage forms? (safety / efficacy may be demanded) Not to forget, Ayurveda encouraged multiple dosage forms (BAHU KALPAM & BAHU VIDHAM).

18 CONCLUSION 1. There is a dire necessity to consider serious amendments to the current D&C Act 1. Industry norms for batch size & specifications 2. Industry standards to be accepted for ASU drugs 2. New doses and dosage forms to be accepted 1. Arogyavardhini ras etc., are to be given official doses 2. New dosage forms like CP bars / biscuits etc. 3. Drug Standards are to be checked against the declared specifications by manufacturers (like USP) 4. ASU advertisements to be controlled with the help of ASCI and industry should support self discipline.

19 Acts and Rules should facilitate industry but, not to frustrate the industry Industry not to resist on Acts and Rules but, to respect the Acts and Rules

20 Thank You

Regulatory & Quality Control Provisions for Ayurvedic, Siddha, Unani and Homoeopathy (ASU&H) Drugs

Regulatory & Quality Control Provisions for Ayurvedic, Siddha, Unani and Homoeopathy (ASU&H) Drugs Dr D.C. Katoch Adviser (Ay.) & Head- Drugs Control Ministry of AYUSH, Govt. of India AYUSH A: Ayurveda