Date Happen Sec. Name Sec.

Name
1898 Code of criminal 1. Title, commencement 24. Cont. of adv.
1919 Poison drug act 2. App. Of other laws 25. Cont. of samp.
1930 Dangerous drug act, Phar. 3. Def. 26. Cont. of labe.
Industry flourish, Sulfanilamide 4. P & R of imp. Of drug 27. Penalties
(107 deaths USA)
1934 Factories act 5. R. of Manu. Of drug 28. Penalties for subseq.
1940 Indian drug and cosmetic act 6. R. of sales of drug 29. Forfeiture
1960 Thalidomide (12,000 deformed) 7. Rrg. of drug 30. Cognizance of offen.
1962 Food, drug & cosmetic act USA 8. PNF 31. DC
1964 Norway medicine good & phar. 9/9A. App. Board/App to 32. Pleas
act PAA
1967 Pharmacy act 10. Com. Of experts 33. Off. By comp.
1969 Shop & establishment ordinance 11/11A. PQCB/Conf. of intr. 34. App. Of law for cust.
1970 Uganda phar. & drug act 12. Pow. To fix max. price 35. Pub. Of off. Name
1968/71 UK medicine act 13. Direc. To PG. 36. Powe. To exempt
1975 Singapore The med. act 14. FDL/FDI 37. Insp.to PS
1976 Drug act, Drug licensing rule, 15. PDTL 38. Indemnity
Appellate board, FI/FDL/FGA, 16. GA 39. Finality of order
Import/export, Germany drug act.
1978 Drug research/specification rule 17. DI 40. Pub of result
1982 Bangladesh drug cont. ord. 18. Pow. DI 41. C/S of L
1986 Label/Packing rules 19. Pro. DI 42. C/S of R
1988 Punj. Drug rule 20. Person disclose area 43. PFG to make R
1996 Fake Men. Vac. Niger (2500) 21. Disclo. Name of 44. PPG to make R
manu.
1997 Contr. Of narcotics 22. Rep. of analyst 45. Repeal & Savings
1998 DEG+PCM cont. (death in peds 23. Imp, manu, sale of
ind. & heiti) drugs
Date Happen Rule Qualifi. Exper. Duration Members
12-02-1976 Drug lis., regis., adv. rule App. Board - - 3 yrs. 11
11-05-1976 Drug act FDI Phar. 10yrs. - -
21-06-1976 Appellate board rule FGA Phar/PC/ 3yrs. - -
Medicine
15-07-1978 Drug research rule DQCA/DQA Phar/PC/ 5yrs. - -
Medicine
23-12-1986 Drug labelling rule (1yr) CLB - - - 13
15-11-2002 Amendments in drug act. Drug reg. - - - 09

Offense Penalties Subsequent License Duration

Sup/un-reg/no. E/L 3yrs not > Life imp. / Not L Import/export 2yrs
dml 10yrs./100,000 5yrs./2lac
Cout.f/False 7yr or 1lac or both Not L 2yrs or M Manufacturing 5yrs.
warranty/Wrong 10yrs./ 2lac/ Both
label/not reg.  Appeal against CLB/RB in 60 days.
 Custom clearance of import in
import/adulterated
10days.
Disobey inspector 1 yr or 10,000 or -  Form fee 50Rs./ Duplicate 25Rs./add
both form 25Rs
Disobey any rule 5yrs/50K or both 7yrs/1lac/both  1% gross profit
Rules Form Purpose Area Purpose
1 Dispose of stock 2000sq yd. Factory plant
2 Recip. For seized drug 200sqft. Inha/HGC/Ext. app/Supp
FDI
3 Purpose of taking sample 250sqft. Eye oint/drops
4 Disp. Of sam. To GA 300sqft. Syrp/elixers/Repacking
5 Disp. Of sam. To GA 300+300 Surgical dressing
FGA 5 Condi. Of seal record 900sqft. coating
6 Report of result of test Manufacturing of drug
A Other than CT Grant Fee Renewal
Drug Research
B Clinical trials Basic 30K 15K
2/5 Impt. Other tha finish 30K 15K
Semi basic
drug
3 Undertak. Of 1lac 50K
Formulation
Import manufacturer
4/6 Impt. Of small quantity Repack 60K 30K
7 Batch certificate Duplicate 1K
8 Report of consignment Areas
9 Expt. Other tha finish Grade Max. no of Max. no of
drug particles/m3 viable/m3
Grade US/FS/209
Export 10 App for lic. E
0.5-5um 75um
11 Undertaking A Class 100 3500 None Less than 1
12 Exp. Of small quantity B Class 100 3500 None 5
Manufacturing 1 Grant C Class 10K 3,50K 2K 100
1A Renewal D Class 1lac 35lac 20K 500
2 Cert. of lic. To manuf.  Validation of lab inst. Annually.
Drugs  Renew lic. Not more than 3M & less than
5 App. For reg & fee 1M.
5A Imported drug  Renew after expiry in 60days with 5K per
5D New molecule day.
5E New drug mol. Patent in  CLB urgent meeting for manuf. In 15days.
PK.  Membership of CLB for 3years with one
further renomination.
 Quorum for CLB meeting should present
one 3rd.
 Inspection report to CLB in 15days.
 DI have to submit report to PQCB in
60days.
 App for DML on form 2 if not satisfied,
apply after 3 and 6M with no fee, but after
that new app with complete fee.
 Drug manufacturing staff 2yrs experience.
 B-II GMP
 B-III M & QC Record