Ayurveda

Regulatory Compliances in Ayurveda – Need of an hour

Ayurveda is the future; people are moving back to nature!

Interestingly, Ayurveda has ability to treat many chronic diseases such as cancer, diabetes, arthritis, and asthma, which are untreatable in modern medicine. Unfortunately, due to lack of scientific validation in various concepts, this precious gift from our ancestors is trailing. Hence, evidence-based research is highly needed for global recognition and acceptance of Ayurveda, which needs further advancements in the research methodology.

Unlike conventional pharmaceutical products, which are usually produced from synthetic materials by means of reproducible manufacturing techniques and procedures, ASU medicines are mainly prepared from materials of herbal origin, which are often obtained from varied geographical and/or commercial sources.

A herbal medicinal product is now being accepted as health care alternative worldwide and is used as both preventive and curative for various types of ailments.The increased global consumption emphasizes the need to address the quality, safety and efficacy concerns, by setting up the policies and regulations on herbal medicinal products. However, challenges like developing globally acceptable products due to differences in regulatory requirements related to quality, safety and efficacy data, differences in the status of ingredients and excipients are hindering the growth of herbal drug industry.

Future of Ayurveda

Ayurveda has been proving its worth since forever, and its positive results have been attracting a large number of audiences to adopt the same in their life. The ancient concept of Ayurveda holds its relevance to date and will continue to do so in the coming future. Increasing awareness about the efficacy of natural and traditional medicines, a surge in research and developmental activities, and less dependency on the allopathy healthcare system, the emergence of self-learned customers, and prevalence of chronic ailments could help in expanding the scope of Ayurveda across the world.

Definition of ASU Medicines

Ayurvedic, Siddha or Unani drug [The term “drug” as defined in the act includes a wide variety of substance, diagnostic and medical devices] includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of 3 [disease or disorder in human beings or animals, and manufactured] exclusively in accordance with the formulae described in, the authoritative books of 4 [Ayurvedic, Siddha and Unani Tibb systems of medicine], specified in the First Schedule;]

Nature of ASU Drugs

• Made from wholesome natural substances of plant, animal, mineral or marine origin.
• Formulation may be of single ingredient or multiple ingredients or combination of different formulations.
• Formulation could be herbal, herbo-mineral or any kind of mixture of two or more natural substances.
• Wholesome extract of medicinal plant (aqueous extract or hydro-alcoholic extract or any other extract) can be the ingredient of ASU formulations.

Broad Types of ASU Drugs

(A) Classical/Shastriye/Traditional: Ayurvedic, Siddha or Unani drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine, specified in the Schedule I of the Act.

i.e such formulations as are described in 103 authoritative books including pharmacopoeias and formularies.

B) Patent or Proprietary: ASU formulations containing only such ingredients, which are mentioned in the formulae described in the authoritative books and do not include a medicine for parenteral administration and the formulation mentioned in any of the authoritative books.

i.e. only ingredients/natural substances mentioned in the authoritative books can be used for manufacturing of patent/proprietary ASU medicines.

Regulation of ASU Medicines

The D&C Act1940 has been described under five chapters (I – V) having total 39 sections. Chapter IVA gives descriptions regarding “Provisions relating to Ayurvedic Siddha and Unani drugs” under section 33 – and 19 subsections i.e B to O. there are two schedules i.e schedule first and second where schedule one enlists prescribed books Ayurveda, Siddha and Unani drugs.

The drugs and cosmetic Rules 1945 has been described under 19 parts (I to XIX) having 169 Rules. Four parts i.e Part 16 to 19 gives description about various Rules related to Ayurvedic Siddha and Unani drugs, under Rules 151 to 169.

There are 25 schedules(A to Y) described under this D&C Rules 1945.

Under these schedules,

Schedule A describes various Forms i.e. Form 1-A, 2-A, 24-D, 24-E, 25 D, 25-E, 26-D, 26-E, 26-E-I,47,48,49 are related to ASU drugs.

Schedule B-1 for fees,

Schedule E(1) enlist poisonous substances under ASU system of medicines and schedule T Good manufacturing practices for ASU medicines.

Provision relating to the manufacture and control of Ayurvedic. Siddha and Unani drugs has been prescribed in the Drugs and Cosmetics Act. The individual section being described here is based on the regulation as prescribed in the Drugs and Cosmetics Act 1940, for the Ayurvedic, Siddha and Unani drugs.

Ayurvedic Manufacturing in India

Licensing authorities

The state Govt. shall appoint licensing authorities by notification in official gazette. [Rule 52]

FOR MANUFACTURER

Application for licence to manufacture ASU drugs

An application for the grant or renewal of a licence to manufacture for sale any ASU drugs shall be made in Form 24-D to the Licensing Authority [State] – Fees INR1000.00 [Rule 153]

Form of licence to manufacture ASU drugs

Subject to the conditions of rule 157 being fulfilled, a licence to manufacture for sale any ASU drugs shall be issued in Form 25-D. [Rule 154]

Certificate of renewal of licence

The certificate of renewal of a licence in Form 25-D shall be issued in Form 26 D [Rule 155]

Duration of Licence

An original licence in Form 25-D or renewed licence in Form 26 –D, unless sooner suspended or cancelled, shall be valid for five years form the date of issue or renewed. [Rule 156]

Condition for the grant or renewal of a licence in Form 25-D

Conditions as specified in Schedule T [Rule 157]

Condition of licence

Licensee shall keep proper record, shall allow the inspector, appointed under the Act, to enter the premises, shall maintain the inspection book Form 35 [Rule 158]

FOR LOAN LICENSE

Application for Loan License

An application for the grant or renewal of a loan license to manufacture for sale of any ASU drugs shall be made in Form 25-E to the Licensing Authority – Fees INR 600.00 [Rule 153-A]

Form of Loan license

Subject to the conditions of rule 157 being fulfilled, a license to manufacture for sale any ASU drugs shall be issued in Form 25-E. [Rule 154-A]

Certificate of renewal of Loan license

The certificate of renewal of a loan license in Form 25-E shall be issued in Form 26 E [Rule 155-A]

Duration of Loan License

An original loan license in Form 25-E or renewed license in Form 26 –E, unless sooner suspended or cancelled, shall be valid for five years form the date of issue or renewed. [Rule 156A]

Condition of license

Licensee shall keep proper record, shall allow the inspector, appointed under the Act, to enter the premises, shall maintain the inspection book Form 35 [Rule 158A]

Cancellation and suspension of license

After 15 days show cause to licensee, in writing, Licensee may appeal within three months

ASU Drugs License Process

• GMP Certificate [Rule 155B]
• Free Sale Certificate
• License validity certificate
• Performance certificate
• Non-Conviction certificate
• Market standing certificate
• YUSH MARK Certificate

Quality Council of India has been engaged for voluntary certification of quality of Ayurveda Siddha Unani (ASU) products. Through this scheme drug manufacturers are awarded quality seal to the products on the basis of third-party evaluation of the quality, subject to fulfilment of the regulatory requirements. AYUSH Standard and AYUSH Premium Marks are awarded for products moving in domestic and international market, respectively.