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