NECESSITY FOR THE CORRECTION OF AYUSH DRUG REGULATIONSbnpl.org.in/PDFfiles/drjlnsastry.pdf ·...
Transcript of NECESSITY FOR THE CORRECTION OF AYUSH DRUG REGULATIONSbnpl.org.in/PDFfiles/drjlnsastry.pdf ·...
NECESSITY FOR THE CORRECTION OF
AYUSH DRUG REGULATIONS
Dr J. L. N. Sastry M.D.(Ayu.); Ph.D.
Head - Health Care ResearchDabur India Ltd.
1. Drugs & Cosmetics Act & Amendment Rules - 1940 & 1945
2. Central Council for Indian Medicine Act - 1970
3. Central Council for Research in Ayu. Sciences - 1978
4. Pharmacopoeial Laboratory for Indian Medicine- 1987
5. Ayurvedic Pharmacopoeia Committee - 1962
1. 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 - 1995 / 2003
Regulatory aspects related to ASU drugs
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; E1 & T schedules for AYUSH
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. 01.02.1983)
Chapter IVA (Act 13 of 1964 w.e.f. 01.02.1969)
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)
D&C Act 1940
Schedule I-A Ayurveda & Siddha systems; schedule I-B Unani-Tibbi System
Part IV & VIImport & Registration (homoeopathy medicines included)
Part XVIMANUFACTURE 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 XVIILABELLING, 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
D&C Rules 1945
D&C Rules 1945 continued ....
Part XVIIIGOVT 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 XIXSTANDARDS 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.
Volume Year of Publishing No of monographs
I 1990 80
II 1999 78
III 2001 100
IV 2004 68
V 2006 92
VI 2008 101
VII 2008 21 (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 2007 50
II 2008 51
III 2010 51
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 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)
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)
What are the aspects Manufacturer should Comply with ?!
Amendments in the Definitions3.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
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.,)
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 anddifferent states have different procedures, panels and there isno uniform system / approach
◦ Rule 160 – Identification of RM by authentic methods (in PLIM)and not by empirical organoleptic evaluation. No penalty tobe imposed before the Central Lab report is obtained
◦ Rule 162 – to be linked to Section 33 G to define thequalifications of drug inspectors in ASU systems
◦
◦ Rule 163A to 167 (PLIM as Central Drug Testing Laboratory forASU drug testing) – the support of industry to be taken for thedevelopment of ASU drug standards. This should be differentfrom APC activity.
Rule 168DRUG 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 ?
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
Amendment….Rule 170
◦ Thanks to Ministry of AYUSH for reconsidering this
amendment
◦ Approval System would be a disaster to the
industry
◦ 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)
Questions to be Answered by APC ?!
Asavarishta dose is fixed at 15-30 ml against (200-400 ml in
Sarngdhara Samhita) ….??
Dose of Arogyavardhini (250-500 mg in place of 6-8 g); Brihat
Vata Chintamani (100-125 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.
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).
Why change of dosage forms OR variants for classical formulations?
CONCLUSION1. 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.
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
Thank You