Ayurveda
Ayurveda is a science of life with a holistic approach to health and personalized medicine. It is one of the oldest medical systems, which comprises thousands of medical concepts and hypothesis.
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
- AYUSH 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.
|
Ayush Standard Mark |
Ayush Premium Mark |
|
Based on compliance to the domestic regulatory requirements |
Based on GMP requirements based on WHO Guidelines and product requirements with flexibility to certify against any overseas regulation provided these are stricter than the former criteria. |
Under this scheme, each manufacturing unit would obtain a certification for its products from a approved certification body (CB) which is accredited to appropriate international standards by the National Accreditation Board For Certification Bodies (NABCB) and will be under regular surveillance of the certification body.
WHO-GMP & CoPP [Ayurveda]
Good Manufacturing Practices (GMP, also referred to as ‘cGMP’ or ‘current Good Manufacturing Practice’) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
GMP defines quality measures for both production and quality control and defines general measures to ensure that processes necessary for production and testing are clearly defined, validated, reviewed, and documented, and that the personnel, premises and materials are suitable for the production of pharmaceuticals and biologicals including vaccines. GMP also has legal components, covering responsibilities for distribution, contract manufacturing and testing, and responses to product defects and complaints. Specific GMP requirements relevant to classes of products such as sterile pharmaceuticals or biological medicinal products are provided in a series of annexes to the general GMP requirements.
The CoPP as per WHO GMP certification are granted by Central Drug Standard Control Organisation (CDSCO). One of the major roles of CDSCO’s zonal office is to participate in the joint inspection for issuance/revalidation of CoPPs as per WHO certification scheme after receiving the application of the manufacturing firm.
contact for more detailsFAQ
What is Ayurveda?
“AYURVEDA” is made up of two words-Ayu and Veda. Ayu means life and Veda means knowledge or science. Thus “AYURVEDA’ in totality means ‘Science of life’. It incorporates all aspects of life whether physical, psychological, spiritual or social. What is beneficial and what is harmful to life, what is happy life and what is sorrowful life; all these four questions and life span allied issues are elaborately and emphatically discussed in Ayurveda. It believes the existence of soul before birth and after death too.
What is the origin of Ayurveda?
Ayurveda, the ancient most health care system originated with the origin of universe. With the inception of human life on earth Ayurveda started being applied. The antique vedic texts have scattered references of Ayurvedic Remedies and allied aspects of medicine and health. Atharva-veda mainly deals with extensive Ayurvedic information. That is why Ayurveda is said to be the off shoot of Atharva Veda.
What are the modes of Ayurvedic treatment?
There exists eight divisions of Ayurvedic therapeutics, namely Kayachikitsa (Internal medicine), Shalya (Surgery), Shalkya (Otorhinolaryngology and Opthalmology), Kaumr Bhritya (Paediatrics, Gynaecology and Obstetrics) Agad tantra (Toxicology), Rasayana (Gerentorology), Vajikaran (Aphrodisiacs) and Bhoot Vidya (Psychiatry).
The principles of treatment are Shodhan (purificatory), Shaman (palliative and conservative), Nidan parivarjan (avoidance of causative and prescipitating factors of disease) and Pathya Vyavastha (do’s and don’ts regarding diets lifestyle). Shodhan therapy includes Vamana (medically induced emesis), Virechana (medically induced laxation), Vasti (medicated enema), shirovirechana (administration of medicines through nose) and Raktmokshan (Blood letting). These therapeutic procedures are collectively known as Panchkarma. Before executing Panch karma treatment Snehan (olation) and Swedan (getting perspiration) are to employed first.
Is Ayurveda recognised by W.H.O?
About 20 years back, W.H.O. adopted Traditional Medicine programme in conjunction with the goal of health for all with the adoption of primary health care approach. W.H.O. has an open mind on Traditional Medicine. However, it endorses only that therapy which has solid scientific evidence with no toxicity. In view of this Ayurveda is duly recognised by W.H.O.
Access to Ayurvedic Medicines
Ayurveda Medicines are being sold in two ways, by practicing Ayurveda doctors and through retail counters. Again retail counters are of two types- purely Ayurvedic & secondly along with allopathic medicines. Classical Ayurvedic medicines as mentioned in original texts of Ayurveda are usually available in former type of counters whereas patent and proprietary medicines are mainly available in allopathic chemist shops. Both types of chemists by and large are available in almost all small and big towns/ cities where from required Ayurveda medicines can be accessed.
Can one take Ayurveda Medicine with modern medicines
If not indicated otherwise by the attending physician, Ayurveda Medicines can generally be taken along with allopathic medicines. Moreover, Ayurveda Medicines are used as adjuvant to allopathic medicines in most of chronic and degenerative diseases. As such there is no harm to consume simple herbal formulations of Ayurveda even without the prescription of the doctor but mineral based medicines must be used after due consultation and advice of the doctor.
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