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Bhaishajya kalpana History of Ayurveda Ras Shastra

Drug and Cosmetic Act 1940 & amp; Rules 1945

Drug and Cosmetic act provides Rules & Regulations for Marketing, Manufacturing, Storing of medicine and Cosmetic products which is mentioned here.

Why is it needed??

Adulteration and substitution causes health problems to person using products manufactured, so it’s necessary to stop ( adulteration and substitution). This comes the need of drug and Cosmetic act.

Details of Drug and Cosmetic act :-

It contains 5 chapters, 38 sections, secdule ( 1 & 2 ), schedule ( a to y ), parts i – ix

  • Chapter 1 :- Introductory Chapter : 1-4 sections ( section 3 for Ayurveda, Sidha, Unani )
  • Chapter 2 :- section 5-7 ( drug conselative committee, drug technical advisory board)
  • Chapter 3 :- section 8-15 ( About raw material)
  • Chapter 4 :- section 16-33 ( manufacturing, marketing, storage)
  • Chapter 4A :– 33B- 33O section ( Rules regarding medicine)
  • Chapter 5 :- 33P- 38 section
  • Secdule 1st A :- Authentic/ Authorized Books for Ayurveda & Sidha.
  • Secdule 1st B :- Authentic/ Authorized Books for Unani
  • Schedule 2 :- Standards to be considered for sale, stocked, or exhibited for sale, distributed Drugs
  • Schedule a to y :-
    • Schedule E ( i ) :- For Ayurvedic Vish Dravya
    • Schedule T :- GMP
  • Part xvi, xviA, xvii, xviii, xix :- for Ayurveda
    • 151-170 Rules
Chapter 1 :-
  • Section 3 ( a ) :- defination : All medicines mentioned under books of section 1, for treatment, diagnosis, cure of diseases, internal or external application are adviced, manufactured with formula mentioned comes under this act.
  • Section 3 ( aa ) :- Formation of Drug Technical Advisory Board for Ayurvedic, Sidha, Unani medicine under section 33C
  • Section 3 ( c ) :- Govt. Analyst : under section 33F central govt. / State govt. Should appoint a govt. Analyst for Ayurveda, Sidha, Unani Medicine
  • Section 3 ( d ) :- Inspector : under section 33G central govt./ State govt. Should appoint a inspector for Ayurveda, Sidha, Unani Medicine
  • Section 3 ( h ) :- Patiented/ Proprighty medicine : medicine should be different from medicine mentioned in books ( section 1 ) but from the constituentes mentioned in them.
Chapter 4A :-
  • Secttn 33B :- this chapter will only be applicable to Ayurvedic/Sidha/Unani medicines
  • Section 33C :- Technical supoort board : central govt. Under section for teachnical management, advices to central and state govt. Should form technical support board for Ayurveda, sidha and unani medicine, various persons should be appointed for the same, central govt. Can appoint any one as head of the board, members.
  • Section 33D :- Advisory committee : for rules for management of ayurvedic/ sidha and unani medicine central govt. Should form advisory committee with 2 members from Central govt. And not more then 1 member from each states
  • Section 33E :- Misbranded drugs : following drugs will be considered Misbranded :-
    1. If medicine is coloured, coated, crushed, polished just to cover the loss of medicine or it appears like before or seems more important then actually is.
    2. If label is not as per rules
    3. If label/ container/ or any other design like saying, design, shape that produces fake understanding/ fake promise
  • Section 33EE :- Adulterated drugs : following drugs will be considered as Adulterated :-
    1. If manufactured completely/ partially in bad utensils, decomposed raw materials, wrong indegriends
    2. Manufactured, packed, stored in unhealthy/ non- sterile environment which leads to loss of health to healthy person
    3. If the container is partially/ completely made up of poisonous compounds which causes loss of health to healthy
    4. For colouring purpose only colour is mixed that’s different from natural colour
    5. If mixed with any posionous/dangerous substance
    6. If mixed with any substance which causes Decrease in quality of medicine manufactured
  • Section 33 ( EEA ) :- Spurious ( fake ) drugs :-
    1. If sold/marketed with the name of another medicine
    2. If medicine is copy of any other medicine or is mixed so that it causes misconception, or labelled with any other medicine, similar to other medicine
    3. If it’s label/ container is mentioned as manufactured with fake/ company or person that doesn’t exist
    4. If completely/ partially component is replaced by substitute
  • Section 33 ( EEB ) :- medicine according to only authorized rules and regulations can be manufactured for sale
  • Section 33 ( EEC ) :- after notice no person can manufacture following for himself or someone else
    1. Selling or manufacture following
      • Misbranded, adultrated or superious drugs
      • Petanted drug without complete and real list of constituents
    2. For breaking any rule and regulation
      • After breaking any rule and regulation under this act the ayurvedic/ Sidha, Unani drug can be banned
  • ** This rule is not applicable to Vaidya/ Hakim who make their own medicine for treatment of their patients
  • Section 33 ( EED ) :- for betterment of society, Indian govt. Can bann any ayurvedic/ sidha or Unani medicine based on proofs related to loss of health of human, animal, facts and gunn doesn’t appear as mentioned
  • Section 33 ( F ) :- govt. Analysist :- Indian govt. After notice should appoint govt. Analysist according to eligibility required
  • Section 33 ( G ) :- Inspector
  • Section 33 ( H ) :- under clause 22, 23, 24, 25 if any rules and regulations is required then inspector and anylist can form regarding drug as necessity
  • Section 33 ( I ) :- plenties regarding breaking of rules and regulations mentioned under this chapter for manufacture, sale are as follows :-
    • Adultrant & without manufacturing license then 1 year of impressment and min. 2000 rs fine.
    • Superious medicine manufacture :- 3 year impressment and min. 5000 fine.
  • Section 33 ( J ) :– repeat breakage of rules leads to twice the plenty and impressment
  • Section 33 ( k ) :- any medicine’s stocks found inappropriate according to this chapter will be seized
  • Section 33 ( L ) :- All rules except 33K will be applicable to govt. Also
  • Section 33 ( M ) :- All plenties and cases will done under presence of inspector and cases in court will require min. Presidentary majistrate or 1st class majistrate
  • Section 33 ( N ) :- after advice central govt. Board can create new rules and regulations under this chapter
  • Section 33 ( O ) :- central government can ammend 1st list of authorized books
  • Section 33 ( P ) :- center govt. Under this can advice new rules to state
Schedule 1st A :- Authorized/ Authentic books
  1. Arkh parkash
  2. Aarogya kalp drumh
  3. Aarya bhaisaj
  4. Astang Hridya
  5. Astang sangraha
  6. Ayurveda kalp drumh
  7. Ayurved parkash
  8. Ayurved sangraha
  9. Bhaisaijaya ratnawali
  10. Bharat bhaisaija ratnakar
  11. Bhav parkash
  12. Brihat nighantu ratnakar
  13. Charak samhita
  14. Chakradutt
  15. Gadh nigraha
  16. Kupipakav rasayan
  17. Nighantu ratnakar
  18. Ras chandanshu
  19. Ras raj chandu
  20. Ras ratan samuchya
  21. Ras tantra saar sidha prayog sangraha
  22. Ras tarangini
  23. Ras yog sagar
  24. Ras yog ratnakar
  25. Ras yog sanghraha
  26. Rasendra saar sanghraha
  27. Ras pradipika
  28. Shastra yog
  29. Sarv rog chikitsa saar ratanam
  30. Sarv yog chikitsa saar ratanam
  31. Shadangara samhita
  32. Sidh bhaisaija manjusa
  33. Sidh yog Sanghra
  34. Sushrut Samhita
  35. Vaidya chintamani
  36. Vaidya shabd sindhu
  37. Vaidyak chiki tyasaar
  38. Vaidya jeevan
  39. Beesvajeevram
  40. Yog rantnakar
  41. Yog tarangini
  42. Yog chintamani
  43. Kahsyap samhita
  44. Bhel samhita
  45. Vishvanath chikitsa
  46. Vrindh chikitsa
  47. Ayurvd chintamani
  48. Abhinav chintamani
  49. Ayurved ratnakar
  50. Yog ratan sangraha
  51. Rasamrit
  52. Dravyagunn nighantu
  53. Ras manjiri
  54. Bagsen
  55. AFI
  56. Ayurved Saar sangraha
  57. API
Schedule 2 : vish drvaya

अहिफेन – Papaver somniferum Linn
अर्क – Calotropis gigantea (Linn)-R: Br:
भगा – Cannabis sativa
दन्ती – Baliospermum montanum
भल्लातक – Semecarpus anacardium Linn.
धत्तूर – Datura metal Linn
गुञ्जा – Abrus precatorius Linn.
जयपाल – Croton tiglium Linn.
करवीर – Nerium indicum Mill.
लांगली – Gloriosa superba Linn
पारसीक यवानी – Hyoscyamus nigar Linm.
स्नुही – Euphorbia neriifolia Linn.
वत्सनाभ – Aconitum feroz
विषमुष्टि – Strychnos nux vomica Linn
Aconitum chasmanthum staff
सर्पविष – Snake poison
गौरीपाषाण – Arsenic
हरताल – Arsenic trisulphide
मन शिला – Arsenic disulphide
पारद – Mercury
रसकर्पूर – Hydragyrum sub chloridum
तुत्थ – Copper sulphate
हिंगुल – Cinnabar
सिन्दूर – Red oxide of lead
गिरिसिन्दूर – Red oxide of mercury

Part XVI : rules for marketing Ayurvedic/ Unani and Sidha medicine :-
  1. Manufacture on more than one set of premises
  2. Licensing Authorities
  3. Application for licence to manufacture ayurvedic, siddha or unani drugs
    • Application for loan licence to manufacture ayurvedic, siddha or unani drugs
  4. Form of Licence to manufacture ayurvedic siddha or unani Drugs
    • Form of loan Licence to manufacture ayurvedic siddha or unani Drugs
  5. Certificate of renewal
    • Certificate of Renewal of A loan licence
    • Certificate of award of good manufacturing practices ayurveda, siddha and unani drugs
  6. Duration of licence
    • Duration of loan licence
  7. Conditions for the grant or renewal of a licence in form 25 D or 26 D
  8. Condition of Licence
    • Condition of loan Licence
  9. Cancellation and suspension of licences
  10. Identification of raw materials
Part XVI A : for raw materials and qualty control laboratory
  • 160 A : Application for grant of approval for testing ayurvedic, siddha und unani drugs
  • 160 B : Form in which approval to be granted for carrying out tests on Ayurvedic , siddha, unani drugs behalf of licences of manufacture
  • 160 C : duration of approval
  • 160 D : conditions for approval
  • 160 E : inspection before grant of permission
  • 160 F : Report of inspection
  • 160 G : procedure of approving authority
  • 160 H : application after rejection
  • 160 I : renewal
  • 160 J : widrawal and suspension of approvals
  • 161 : labeling, packing and limit of alchol
  • 161 A : Exemption of labelling and packaging provinces for export for Ayurvedic/ Siddha, Unani drugs
  • 161 B : period of shelf life
Part XVIII : analysist and inspector
  • 162 : Duties of Inspectors specially authorized to inspect the manufacture of ayurvedic (including siddha) or unani drugs
  • 162 A : Qualifications for state drug licencing authority for licensing of ayurveda. siddha and unani drugs
  • 163 : Procedure for Dispatch of sample to government analyst and its receipt by the govt. analyst
  • 163 A : Functions of the pharmacopoeiaal laboratory for indian medicine, Ghaziabad
  • 163 B : Functions of the Director. FILM- Ghaziabad
  • 163 C : Dispatch of samples for test or analysis
  • 163 D : Recording of condition of seals
  • 163 E : Report of result of test or analysis
  • 163 F : Fees
  • 163 G : signature of certificates
  • 164 : Method for test or analysis to be employed in relation to ayurvedic (including siddha) or unani drugs
  • 165 : Qualifications of government analyst
  • 166 : Functions of government analyst
  • 167 : qulatifications of inspector
Part XIX :
  • 168 : Standards to be complied with in manufacture for sale or for distribution of ayurvedic, siddha and unani drugs
  • 169 : Permitted excipients
  • 170 : Guidelines for evaluation of Ayurveda, siddha and unani drugs and other traditional medicines of India.
Schedule A :-
  • 24D : Application for the grant/renewal of licence to manufacture for sale of ayurvedic: siddha or unani drugs
  • 24E : Applications for grant or renewal of a loan licence to manufacture for sale of ayurvedic including siddha or unani drugs
  • 25D : Licence to manufacture for the sale of Ayurvedic (Including siddha) or unani drugs
  • 25 E : Loan licence to manufacture for sale ayurveda (Including siddha) or unani drugs
  • 26D : Certificate of renewal of licence to manufacture medicine for sale ayurvedic (Including siddha) or unani drugs
  • 26 E : Certificate of renewal of loan licence to marfacturer for sale ayurvedic (Including siddha) or unani drugs
  • 26 EI : Certificate of good manufacturing practice (GMP) to manufacturer of ayurvedic (Including siddha) or unani drugs
  • 47 : Application for grant or renewal of approval for carrying out tests on ayurvedic, siddha and unani drugs or raw material used in the manufacture there of on behalf of licensees for manufacture for sale of ayurvedic, siddha and unani drugs
  • 48 : Approval for carrying out tests or analysis on ayurvedic, siddha and unani drugs or raw material used in the manufacture thereof on be half of licensees for manufacture for sale of ayurvedic, siddha and unani drugs
  • 49 : Certificate of renewal for carrying out tests or analysis on ayurvedic, siddha or unani drugs or raw materials used in the manufacture there of on behalf of licensees for manufacture for sale of ayurvedic, siddha or unani drugs
  • 50 : Report of test or analysis by approved laboratory

Schedule B -1 : Fees for the test or analysis by the
pharmacopoeial laboratory for Indian medicine (PLIM) or the government analyst

Schedule – T : GMP

Schedule – Y : Requirements and guidelines for permission to import and or manufacture of New Drugs for Sale or to undertake clinical trials