Rules and Regulations

Renewal Omitted: No Need for Renewal of Pharmaceutical Drug Licences and its Effect

With effect from new amendment in Drug and Cosmetic Act, 1945, you will not need for renewal of your drug license in future. If you have Retail/Pharmacy, Wholesale/Distribution, Loan or Manufacturing License Form* for pharmaceutical and cosmetic preparations then you will have no need to renew it.

You only need to deposit license retention fee before expiring of a period of every succeeding five years from date of issue of its issue, unless it is suspended or cancelled by licensing authority.

In case Licencee failed to deposit this fees at due time, then licencee shall be liable to pay licence retention fee along with a late fee calculated at the rate of two percent. In case of of non payment till six month, License shall be deemed to have been cancelled.

This amendment will be beneficial for all pharma business correspondents. It was tricky process to renew drug license. One has to follow complete process as in case of new license.

Now this amendment will provide relief to all manufacturing, wholesale and retail licencee whose licence were due this year and in future.

But few rules also been added through this amendment. Now your premises will be inspected by drug inspector at compulsory basis for minimum of one time in three year. Maximum number of inspection could be as needed as per risked based approach.

More rule is added in the provision.

For Retail and Wholesale: – Inspection for verification of compliance:  “The licensing authority shall cause inspection, by the Inspector  appointed under the Act, of each premises licensed under this Part, to verify the compliance with the conditions of licence and the provisions of the Act and these rules, not less than once in three years or as needed as per risk based approach.”

For Manufacturing and Loan Licensing:-  Inspection for grant of licence and verification of compliance.-

“(1) Before a licence in Form —–* is granted, the licensing authority shall cause the establishment in which the manufacture of drugs is proposed to be conducted or being conducted to be inspected jointly by the Drugs Inspectors appointed by the Central Government and the State Government under this Act who shall examine the establishment intended to be used or being used for the manufacture of drugs.

(2) The premises licensed under sub-rule (1) shall be inspected jointly by Inspector appointed by the Central Government and State Government to verify the compliance with the conditions of licence and the provisions of the Act and these rules not less than once in three years or as needed as per risk based approach.”

Same rules will also be applicable for manufacturing and loan licensing of cosmetic and Homeopathy products.

Effect of omitting Renewal at Pharmaceutical Sector:

  1. Renewal was a time consuming process. This will prevent time consumed during this process.
  2. It will build transparency in drug license process.
  3. Work Overload of drug department will be less. Now Drug Department can concentrate at proper implementation of laws and rules according to Drug and Cosmetic Act.
  4. Inspection will be compulsory. It will forced licencee to fulfill all requirements as drug department may conduct inspection at regular basis.
  5.  This amendment is focus at implementing good manufacturing standards as new plants will be inspected by Joint team of Center and State Drug Authority.
  6. Quality of Products manufactured in India may improve as manufacturing standard compliance could be regularly checked.
  7. More control of Drug Authorities will be at ground level for maintaining standards and availability of quality products.

* Form:

Form 19, Form 19A, Form 19AA and Form 19C, Forms 20, 20A, 20B, 20BB, 21C, 21CC, 20F, 20G, 21, 21A, 21B or Form 21BB,  Form 24, Form 24A, Form 24B, Form 24C, Form 24F, Form 25 or Form 25A or Form 25B or Form 25F, Form 26, Form 26A, Form 26B, Form 26F, Form 26H, Form 27, Form 27A, Form 27B, Form 27D, Form 27DA, Form 28 or Form 28A or Form 28B or Form 28D or Form 28DA, Form 31 and Form 31A, Form 32 or Form 32A, Form 33, Form 33, Form 33A, Form 37 and Form 38. Know more about form Read our Article: Types of Licences required to start business in Pharmaceutical Sector

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