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DCC asks DCGI to issue advisory to all SLAs to ensure that only pharma grade excipients are used in drugs
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Gireesh Babu, New Delhi
November 25 , 2023
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In an effort to address the quality issues of the excipients including the propylene glycol used in cough syrups, the Drugs Consultative Committee (DCC) of the Union health ministry has recommended to the national drug regulator to ensure that only pharma grade excipients are used in manufacturing of drugs as per the Drugs and Cosmetics Act.
A recent meeting of the DCC, convened under the chairmanship of Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi, opined, "that as per the Drugs and Cosmetics Act only pharma grade excipients shall be used and therefore proper enforcement need to be done to tackle the issue."
The Committee recommended issuing an advisory to all State Licensing Authorities (SLAs) to direct all the manufacturers under their jurisdiction to use only pharma grade excipients for manufacturing of drug formulations.
"The sub-committee may be constituted for examining the matter and give a comprehensive report within three months' time," said the 62nd meeting held in hybrid mode at the end of September, 2023.
The Committee was considering a proposal for appropriate regulatory intervention to ensure that the safe and pharmaceutical inactive bulks imported or manufactured are used in drug formulations.
It observed that in the recent risk-based inspections and related to international complaint investigation, it was observed that excipients like glycerin, propylene glycol etc. were imported from different countries as industrial grade and supplied by traders or not by those who are not licensed under the Drugs and Cosmetics Act and Rules to the pharmaceutical manufacturing units.
It may be noted that the World Health Organisation and the health ministries of some of the importing countries such as Gambia has accused that the cough syrups manufactured in India had unacceptable amounts of diethylene glycol and or ehtylene glycol as contaminants.
The DCGI has also directed the industry not to purchase propylene glycol from a Delhi-based Maya Chemtech India as it is not of standard quality. The issues related to the quality of cough syrup have also impacted the reputation of Indian manufacturers in some of the export markets, according to reports.
The DCC was apprised that adulteration of pharmaceutical excipients has been reported several times and the control of pharmaceutical excipients is important with regard to their quality specification as they are directly used in manufacturing of formulation.
The Committee received representation that technical/industrial grade gelatin imported from China is being used for the manufacture of capsules (soft/Hard). Further, Madhya Pradesh-based Nagrik Upbhokta Margdarshak Manch has also reported that some of the capsule manufacturers are knowingly or unknowingly using industrial grade gelatine imported from China in the manufacturing of capsules intended for human consumption.
There is increasing evidence that low cost industrial/technical grade gelatine unfit for human consumption is being imported mainly from China, by unscrupulous traders and sold to soft capsule manufacturers who blend it with high quality gelatin made in India, in the manufacturing of capsules.
Technical gelatin is prohibited for human consumption due to the presence of certain toxic (carcinogenic) compounds of chromium etc as there is no regulation specifying maximum limit of chromium/other heavy metals/salmonella and requirement for drawl of samples for testing of industrial grade gelatin to ensure safety.
Similarly, while 170,000 MT of IPA (isopropyl alcohol) is consumed by the pharmaceutical industry in the country only about 15-17% is pharmacopoeia grade. India imports around 120,000 MT of industrial grade IPA. Thus Industrial grade IPA lands in the pharma industry, apart from serving the other industries like coatings, cleaning etc. Imports mainly come from China, South Korea, Taiwan, Europe, and the USA.
IPA is an important solvent for pharmaceutical applications. However, usage of industrial grade IPA that does not fulfill pharmacopeia criteria is dangerous and hazardous to health. Industrial grade IPA, which does not meet various critical parameters covered in Pharmacopeia Standards such as UV absorbance test, identification of unsaturated hydrocarbons and rapidly carbonizable material can adversely affect the quality of the drug.
According to the Rule 24A (8) of the Drugs & Cosmetics Act & Rules, no import registration certificate is required in respect of an inactive bulk substance. However, Rule 43 and Schedule D of the Act provide exemption for Substances not intended for medicinal use excluding those intended to be used as drugs after further purification or rendering them sterile.
"Dual Use NOCs issued by CDSCO include the excipient category. The excipients like Hard Gelatin capsules, glycerin IP etc., imported under Dual Use NOCs, should be used for non medicinal purposes only," observed the Committee.
The Drug definition under the Drugs and Cosmetics Act, 1940 includes all substances intended for use as components of a drug including empty gelatin capsules that are required manufacturing licence and compliance of GMP is mandatory.
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