Domestic drug manufacturers seek Centre intervention to decriminalize errors by licensed manufacturers in D&C Act

In order to address the issue of menace of spurious drugs and as recommended by the Mashelkar Committee, the penalties under Section 27 were substantially enhanced and made more stringent vide Drugs and Cosmetics (Amendment) Act, 2008.

By:November 3, 2021 5:28 PM
Centre, D&C Amendment Act, 2008, labelling errors, FOPEInternationally, the emphasis of enforcement agencies is on compliance and a similar approach is also required to be adopted in India.

Domestic drug manufacturers have sought Centre’s intervention to decriminalize errors by licensed manufacturers in Drugs and Cosmetics (Amendment) Act, 2008 as current tone of the provisions under the Act emphasises on penalising the offenders for any contravention of any of the provision under the said Act.

The prohibitions are provided under Section 18 of the D&C Act, while penal provisions are under Section 27 of the said Act.

In order to address the issue of menace of spurious drugs and as recommended by the Mashelkar Committee, the penalties under Section 27 were substantially enhanced and made more stringent vide Drugs and Cosmetics (Amendment) Act, 2008. However, the unintended consequence of the said amendment is that the licensed manufacturer’s unintentional non-compliances are also facing a lot of hardships. The prosecutions are even being filed for minor offences like labelling errors rendering the drug as misbranded.

According to Harish K Jain, Senior Vice President and Chairman, Regulatory & Technical Committee, Federation of Pharma Entrepreneurs (FOPE), “There is need to decriminalize the unintentional errors, non-compliances not having direct impact on the quality and are of lesser gravity, by the licensed manufacturing entities. It is necessary to introduce the provisions for imposing the financial penalties, except for those offences not related to Spurious or Adulterated drugs, for the non-compliances instead of punishment of imprisonment.”

“Internationally, the emphasis of enforcement agencies is on compliance and a similar approach is also required to be adopted in India. Therefore, suitable amendments to provide for the issue of compliance notice should be made in Rule 85 of the Drugs Act and opportunity should be given to the licensee for compliance of the observations recorded by the inspecting officers and report compliance,” Jain clarified.

Drug manufacturers have argued that the merits and technical aspects are generally not properly appreciated in the Courts. The deterrent effect of enhanced punishment is lost due to delay in deciding the cases and purpose of having deterrent effect on offenders carrying out clandestine activities of manufacture, sale and distribution of adulterated and spurious drugs also does not seem to have been achieved.

“It is therefore necessary that the prosecutions may be launched only in cases of Spurious Drugs or Adulterated Drugs and in all other cases the offences may be adjudicated and penalties in terms of fine may be imposed. Such provisions are already made under Food Safety and Standards Act, 2006 and prosecutions are lodged only in cases of unsafe food and other offences are compounded through adjudication. Such provisions in the Food Safety and Standards Act, 2006 has worked out to be effective,” drug regulatory experts explained.

Current D&C Act, 1940 is enacted with an object to regulate manufacture, import, sale and distribution of drugs. The emphasis is on total quality management with respect to the drugs by providing for various definitions of the standard quality, spurious drug, adulterated drug and misbranded drugs. It also provides for the requirements to be complied by the manufacturer and other stakeholders in the supply chain.

 

 

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