Synopsis of the Drugs and Cosmetics Rules, 2018
Introduction
Drugs and Cosmetics Act, 1940 (hereinafter referred to as the ‘Act’) and Rules 1945 (hereinafter referred to as the ‘Rules’) were passed with the aim to ensure that only qualified personnel are engaged in manufacturing, importing, distribution and sale of drugs and cosmetics, confirming safe and effective drugs and cosmetics are being sold. It also prevents entry of substandard drugs and cosmetics in the Indian market. The Act and the Rules have been amended several times since coming into force to meet the need of the hour.
Amendments
The latest amendments made in the Rules are for implementation of increase in application fees for grant of various import licenses, registration certificates for Drugs and Cosmetics and permission for import of New Drugs and Fixed Dose Combinations. These amendments have been brought vide the Drugs and Cosmetics (Tenth Amendment) Rules, 2018 w.e.f. October 12, 2018. The Ministry of Health and Family Welfare directed concerned officers in Central Drugs Standard Control Organization (CDSCO) (HQ) and its Zonal, Sub-zonal and Port offices to ensure implementation of the above amendment via office memorandum [1] dated December 17, 2018.
Increase in import licence fee for drugs
The application fee for obtaining import licence by a person who has a valid wholesale licence for sale or distribution of drugs has increased from INR 1000 (USD 15 approx.) to INR 10,000 (USD 150 approx.) for single drug and additional fee has also been increased from INR 100 (USD 1.5 approx.) to INR 1000 (USD 15 approx.). Furthermore, fees for obtaining a duplicate copy of the said licence has been increased to INR 1500 (USD 22 approx.) as compared to earlier fees of INR 250 (USD 4 approx.).
Increase in fees for obtaining Registration Certificate
A person having a valid wholesale licence for sale or distribution of drugs now has to pay USD 10,000 and additional fee of USD 5000 for additional drugs as opposed to USD 1500 and USD 1000 for additional drug pre-amendment. Furthermore, payment of USD 25,000 has to be made towards inspection or visit of the manufacturing premises or drugs by the licensing authority. Additionally, USD 1800 or its equivalent in Indian rupees shall be paid for making amendment in the registration certificate or issuing duplicate certificate whereas the fees pre-amendment was USD 300.
Increase in fees for obtaining licence for examination, test or analysis
The application for obtaining licence for examination, test or analysis shall be accompanied by INR 5000 (USD 71 approx.) for a single drug and an additional fee of INR 2000 (USD 29 approx.). Earlier the fee was INR 100 (USD 1.5 approx.) for a single drug and an additional fee of INR 50 (USD 1 approx.).
Fees for obtaining licence for importing small quantities of new drug
Any Government Hospital or Autonomous Medical Institution who wishes to obtain licence for importing small quantities of new drug for treating its patients has to file an application along with INR 600 (USD 9 approx.) for a single drug and an additional fee of INR 300 (USD 5 approx.) as compared to the earlier fee of INR 100 (USD 1.5 approx.) for a single drug and an additional fee of INR 50 (USD 1 approx.).
Import or Manufacture of new drug for Clinical Trials or Marketing
The fees accompanied with application for grant of permission to import a new drug has been increased from INR 50,000 (USD 706 approx.) to INR 2,50,000 (USD 3526 approx.). Likewise, an application for permission to import or manufacture fixed dose combination of two or more drugs had to be earlier accompanied with INR 15,000 (USD 212 approx.). However, post-amendment the fee has been modified as INR 15000 (USD 212 approx.) in case of application for manufacture of the fixed dose combinations and INR 1,00,000 (USD 1412 approx.) in case of import application of the fixed dose combinations.
Import and Registration of Cosmetics
In order to obtain licence to import cosmetics, the concerned application has to be now accompanied by USD 2000 or its equivalent in Indian rupees for each brand of cosmetic and a fee of USD 50 for each variant, whereas earlier the fees was USD 250 for each brand irrespective of number of variants. Moreover, the fees for obtaining duplicate licence has been increased to USD 500 from USD 100.
Conclusion
The application fees for grant of various licences relating to import of drugs and cosmetics has been substantially increased. The Ministry of Health and Family Welfare has also taken due steps to ensure that these amendments are properly enforced. However, the effect of these amendments in the drugs and cosmetics sector is yet to be noticed.
________________________________
[1]
Office Memorandum F. No. 18-68/2018-DC dated 17.12.2018 available at https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjMzNw== .