DRUGS:

Drugs are generally classified as the medicines which are used to cure mental and physical health withstanding to biochemicals and natural ingredients; According to section 3 (b) of Drugs and Cosmetics Act it includes—

  • all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;
  • such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of 6 [vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;
  • all substances intended for use as components of a drug including empty gelatin capsules; and
  • such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board
  • AYURVEDA DRUGS:

Ayurveda is referred as the ancient Indian Medical system and it is the worlds oldest medical system that is used to cure the consumer, with regard to natural ingredients doses, diets and life style; Wherein, according to section 3 (a) of Drugs and Cosmetics Act it 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].

  • REGULATORY BODIES AND GOVERNING STATUTES:
  1. REGULATORY BODIES:

Ayurveda Drugs in India are majorly regulated by G.O.I through:

  1. Drug Controller General
  2. Ministry of Ayush
  • GOVERNING STATUTES:

A list of statutes that lays down procedural and substantive laws with respect to drugs are listed here in under;

  1. Drugs and Cosmetics Act 1940
  2. Drugs and Cosmetics Rules 1945
  3. The Indian Prevention of Food Adulteration Act 1954
  4. The Indian Prevention of Food Adulteration Rules1955
  5. The Food Bureau of Indian Standard Act 1986
  6. Drug Control Act 1950
  7. The Ayurveda Central Council Act 1970
  • MANUFACTURING AYURVEDA DRUGS!!!
  1. Essentials

To manufacture Ayurveda Drugs, a Licence is to be obtained from the licencing authority, that has been appointed by the state government, wherein, below mentioned requirements are met.

  1. Pharmacist: The pharmacist shall possess requisite qualifications in the case of a retail business. Whereas, withstanding to a wholesale business, the pharmacist must be a graduate, in addition to, 1-year experience/an undergraduate with 4 years’ experience.
  2. Space Requirement: The other important requirement is space, that is the area of the pharmacy/unit.
  3. Wholesale and Retail License – 15 square meters.
  4. In other cases – 10 square meters.
  • Storage Facility: some drugs require to be stored in low temperatures, refrigerators and air conditioners are a must.
  • General Requirements for Manufacturing Ayurveda Drugs:
  1. LOCATION AND SURROUNDINGS.  (non-residential area and hygienic) (10 – 150 square feet variable, pertaining to drugs.)
  2. BUILDINGS (walls to be 6 feet erected; flooring to be smooth and washable)
  3. WATER SUPPLY (potable quality)
  4. DISPOSAL OF WATER (suitable arrangements for waste water)
  5. HEALTH, CLOTHING AND SANITARY REQUIREMENTS OF THE STAFF
  6. MEDICAL SERVICES (First Aid)
  7. WORKING BENCHES (for the operation of drugs)
  8. ADEQUATE FACILITIES (for washing and drying of containers)
  • MANUFACTURING RECORDS:
  • Maintaining of manufacturing records is mandatory as per section 18(B) of Drugs and Cosmetics Act, non-compliance to which shall attract a penalty in addition to imprisonment.
  • Particulars that are to be mentioned in manufacturing Records:

Serial number; Name of the product; Batch size; Batch number; Name of all ingredients; Quantities used; Actual production; Packaging particulars indicating the size and quantity of finished packings; and Signature of the expert staff responsible for the manufacture.

  • MANUFACTURER’S RESPONSIBILITY:
  • A manufacturer is responsible to ensure Rationality; Safety; Ensure Quality and Quantity of the various excipients used in formulation of the drugs.
  • Manufacturer shall continue to provide and maintain the premises, equipment and staff as at the time of grant of license.
  • Manufacturer shall test each batch of raw material before its use in the manufacture.
  • Manufacturer shall to test each batch of finished drugs.
  • Manufacturer shall maintain records of raw material.
  • Upper limit of alcohol shall not exceed more than 12 v/v except those that are notified by the Central Government.
  • Natural colouring agents to be used specifically
  • Preservatives and colouring agents if any shall be mentioned on the label
  • Additives used, if any, shall be mentioned on the label with the quantity used. Artificial sweeteners may only be used ASU products and same shall be mentioned on the label with a statutory warning.
  • DRUGS THAT ARE NOT TO BE MANUFACTURED/SOLD:

With regard to the guidelines laid under Drugs and Cosmetics Act 1940 and Rules 1945 certain Drugs are neither to be manufactured, nor to be sold; such Drugs are disclosed here in under;

  1. Drugs that are Misbranded
    1. Drugs that are Spurious
    1. Drugs that are Adulterated
    1. Drugs that are Unlicensed
    1. Drugs that are Prohibited
    1. Drugs that are Patented or Proprietary, wherein, ingredients used can’t be disclosed.
  • LABELLING REQUIREMENTS FOR DRUGS:
  1. Name, manufacturing address and pin code is to be mentioned over the drug.
  2. Net contents and Ingredients are to be specified.
  3. Directions of use are to be mentioned, if any.
  4. Names and net content of ingredients are to be specified, if consists of any hazardous ingredient
  5. Quality standards are to be specified in accordance with Bureau of Indian standards.
  6. Distinctive batch number followed after letter B, in addition to manufacturing license number followed by letter M; to be specified on label.
  • LICENCES & DOCUMENTS REUIRED TO ACQUIRE LICENCE:
  1. LICENCES:

Different types of licence required for the sale of drugs (the required number of application form for a particular licence is mentioned in the bracket) are given hereunder: –

  1. Licence on Form 20 is issued for the sale of Allopathic drugs by retail other than those specified in Schedule C, C (1) and X. (Form-19)
  2. Licence on Form 20-A is issued for the sale of restricted Allopathic drugs by retail other than those specified in schedule C, C (1) and X. (Form-19A)
  3. Licence on Form 20-B is issued for wholesale of Allopathic drugs other than those specified in Sch C, C (1) and X. (Form-19)
  4. Licence on form 20-C is issued for sale of Homoeopathic medicines by retail. (Form-19B)
  5. Licence on Form 20-D is issued for sale of Homoeopathic Medicines by wholesale. (Form -19B)
  6. Licence on Form 21 is issued for retail sale of Allopathic drugs specified in Sch C & C (1). (Form-19)
  7. Licence on Form 21-B is issued for wholesale of Allopathic drugs specified in Sch C & C (1). (Form-19)
  8. Licence on form 21-A is issued for retail sale of restricted Allopathic drugs specified in Schedule C (I). (Form-19A)
  9. Licence on Form 20-F is issued for retail sale of drugs specified in Sch. ‘X’. (Form-19-C).
  10. Licence on Form 20-G is issued for wholesale of drugs Specified in Sch. ‘X’. (Form-19-C)
  • DOCUMENTS MANDATORY TO BE ANNEXED WITH APPLICATION:
  1. Certain documents are necessary to be annexed while applying for the licence with regard to the clearance and No Objection Certificate. A list of such documents necessary is tagged herein’
  • Application Form
  • Online payment: Fees of Lic. Rs. 6000/- + Inspection Fees Rs. 1500/-
  • Declaration Form
  • Proof of Constitution of Firm in case of Partnership / Pvt. Ltd./ Ltd. /Trust.
  • Copy of Resolution passed by Board of Directors.
  • Key Plan and Site Plan in Blue Print / Ammonia Print.
  • Proof of Possession: A) Rented: Rent Receipt & Rent Agreement. (Notary Attested) B) Self Occupied.
  • Proof of Ownership: Copy of Regd. GPA / Sale Deed / Property Tax Receipt
  • Affidavit of Non-Conviction as per format given in Guide Line Booklet.
  • List of Equipment and Machineries Provided for Manufacturing.
  • List of Equipment Provided for Testing.
  • List of Technical Staff for manufacturing along with their Self Certified photocopies w.r.t. Certificates of Education Qualification, Experience Certificate, Biodata on Proforma, Appointment Letter, three photographs.
  • List of Technical Staff for testing along with their Self Certified photocopies w.r.t. Certificates of Education Qualification, Experience Certificate, Biodata on proforma, Appointment Letter, three photographs.
  •  Affidavit from employer and or Technical Staff for full time working with the firm as per format given in Guide Line Booklet.
  • List of Formulations to be permitted along with product information separately for each drug and affidavit about owner / user of the trade name applied for.
  • Consent of Approved Testing Laboratory for Sophisticated Testing.
  • Kindly refer “Drugs and Cosmetics Act, 1940 and Rules made there under” for more information.
  •  At present, as per department policy “Licences are being granted in Industrial Area only”.
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