Pharma Printers must come under the ambit of Drugs Act

In another case DCA Telangana conducted raids on the places of counterfeiter and recovered many counterfeit drugs

N K Ahooja

March 27, 2024

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N K Ahooja

Advocate |
Professor, MVN University Palwal, Haryana |
Former State Drugs Controller |
Food and Drugs Administration, (FDA) Haryana, India |
Email: narendervivek16@gmail.com

Counterfeit drugs

Counterfeit drugs are posing a threat to the Indian pharmaceutical industry. Counterfeiters are manufacturing drugs which belongs to other company in their name and style.

Most of the time counterfeiters are not even adding any active pharmaceutical ingredients (API) in these products.

The counterfeit drugs which are even not having the APIs are causing the health hazard.

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As the patients are consuming these drugs but actually these drugs are not having the active ingredients and have no pharmacological action.

The Menace of Counterfeiting

These counterfeiters are supplying the drugs without any invoices without issuing any bills therefore even when the counterfeit drugs seized in the market by the drug inspectors, it becomes very tough for the investigating officer to reach actually who has manufactured these counterfeit drugs.

Without establishing the supply chain of these drugs investigations could not reach up to the counterfeiters.

In these cases, the inspectors are issuing notices to the manufacturer whose name is disclosed on the label but who is not the actually manufacturer of this product.

Rather the name of manufacturing unit on the label is a victim of the fraud of the counterfeiters.

When these genuine manufacturers tried to protect their brand becomes whistle blowers but sometimes feels harassed and frustrated due to certain lacunae in law and casual approach of investigation.

Recent Cases highlights the severity

in a very recent case FDA officers of Chhattisgarh raided and took hold of Distributor swapping labels and secondary packing of Eye Drops removing the labels and box of one company and pasting the label and secondary box of other company due to price difference.
In another case DCA Telangana conducted raids on the places of counterfeiter and recovered many counterfeit drugs.

Legal Regulatory Solution

Packing Material:

The word manufacturer is defined in the Drugs and Cosmetics act 1940 in Section 3(f) which includes ‘packing’.

Packing of any drug is not possible without ‘printed packing material’ and ‘printed secondary boxes.

Then why these printers who are supplying the printed primary and secondary packing materials to is counterfeiters should not be held responsible as they are printing and supplying this printed packing material without ascertaining if it actually belongs to the counterfeiters.

Therefore, these printers printing packing materials for counterfeiters are actually culprit and main accused with counterfeiters. Section 120 B can be invoked against these printers.

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Excipients:

Section 3(b) (iii) part of definition of Drug prescribed “all substances intended for use as components of a drug” are also drug.

All the excipients and additives including empty gelatin capsule are included as drug by virtue of this definition. However, this does not include the printed packing materials.

But taking a clue from this definition the printed packing materials which are integral part of the drug may be regulated which is need of the hour.

Rule 104:

A prohibition against altering inscriptions on containers labels or wrappers of drug in which a permission or registration is required from the competent licensing authority even for stickering.

Even when the rates are reduced by issuing gay notification of ceiling price by National Pharmaceuticals Pricing Authority (NPPA). This proves beyond doubt that packing is regulated.

Schedule M:

That the Schedule M read with Rule 71, 74,76 and 78 which prescribe Good Manufacturing Practices (GMP) for Pharmaceutical Products at Sr. no. 17 under heading Specifications provides common specifications at point 17.1 ‘For Raw Materials and Packaging Materials’ which proves and equates the importance of Packing Materials with Raw Materials.

In case of Raw Materials even for Additives Excipients etc. having No Pharmacological Action there is a requirement of Drug Manufacturing License under Drugs Act 1940 but for printed packing material there is no such regulatory pathway.

Click for more articles on Schedule M

Proposed Solutions

Regulators: Regulators must prescribe a method of Licensing / Registration for printers of packaging materials, ensuring accountability and traceability.

Pharma Printers: All pharma printers must verify the following:

Copy of License and its validity at the time of taking order from its actual manufacturing unit.
Printer should check the product approval issued by competent authority in favour of manufacturer.
Printer must get a final signed approval on specimen of printed packing material before commencing the printing on commercial scale.
Printer should keep the records of actual printing rolls, quantity printed, copy of Drug manufacturing License (DML) of manufacturer, order of manufacturers with date and quantity, Final supply with receipt by authorised person only.
Printer must keep a record of Security Features included in printed packing materials which can be used during Investigations by Drugs Inspectors.
Rolls used for printing should be either in exclusive possession of Brand owner or a double lock system may be used.
For Contract manufacturer or marketing firms the printed packing material should be a joint responsibility of manufacturer marketer and printer. All these should be held responsible.
Printer premises printing Packing Materials for Drugs should remain open for Inspection at least once in a year as prescribed under Rule 52 which are duties of Inspectors for manufacturing units and are subject to instructions of Controlling Authority.
Printing of Printed Packing Materials for Counterfeiters should be made punishable under Drugs Act also and same penalties may be prescribed which are for Spurious or Unlicensed Manufacturers.

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