Check by Department
Legal Compliance Checklist – Regulatory
| Sr. No. | Legisltion Category | Statute | Legal Provision | Compliance | Applicability | Penal Provision | Required Forms |
|---|---|---|---|---|---|---|---|
| 1 | Regulatory | Drugs and Cosmetics Act, 1940/Drugs and Cosmetics Rules, 1945 | Section 12 (2) read with Rule 23 | Obtain import licence in Form 10 for the import of drugs, not specified in Schedule X. | Every person or company on import drugs not specified in Schedule X. | Imprisonment upto 3 years or Fine upto Rs. 5,000/- or Both and on subsequent offence imprisonment upto 5 years and Fine upto Rs. 10,000/- or Both (Section 13) | Form no. 10 |
| 2 | Regulatory | Drugs and Cosmetics Act, 1940/Drugs and Cosmetics Rules, 1945 | Section 33 (2) read with Rule 24-A (1) | File an application for the issue of a registration certificate, in Form 40 along with the prescribed fees and the information and undertakings specified in Schedules duly signed by or on behalf of the manufacturer for registration certificate to the Licensing Authority. | Every manufacturer having valid wholesale licence for sale or distribution of drugs or by the manufacturer’s agent in India having a valid licence to the manufacture for sale of drug or having a valid wholesale licence for sale or distribution of drugs for the import of drugs. | Imprisonment upto 5 years and with Fine which shall not be less than one lakh rupees or three times the value of the drugs confiscated, whichever is more (Section 27 (b)) | Form no.40 |
| 3 | Regulatory | Mines Act, 1952/Mines Rescue Rules, 1985 | Section 58 read with Rule 5(2) | Establish a rescue room irrespective of the number of persons ordinarily employed below-ground | Below ground coal mines having a fiery seam / gassy seam of second or third degree | Imprisonment unto 6 months or fine unto Rs. 2000/- or both (Section 72A) | NA |
| 4 | Regulatory | Mines Act, 1952/Mines Rescue Rules, 1985 | Section 58 read with Rule 11 (7) | Intimate the accident in Form II to the Chief Inspector and Regional Inspector within 24 hours by the Manager | Accident in a below ground mine arising out of the use of any rescue apparatus | Imprisonment unto 6 months or fine unto Rs. 2000/- or both (Section 72A) | II |