New Delhi: In a shocking revelation, the Central Drugs Standard Control Organization (CDSCO), has flagged over 50 commonly used medications, including household names like Paracetamol and antacid Pan D, for failing to meet safety and quality standards.
Deeming them as &ldquo;not of standard quality&rdquo;, the CDSCO has sparked worry among healthcare professionals and citizens alike. These findings, released in a recent alert, have sparked significant worry among consumers and healthcare professionals alike.&nbsp;
<span style="font-size: 12.0pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Calibri; mso-bidi-theme-font: minor-latin; border: none windowtext 1.0pt; mso-border-alt: none windowtext 0in; padding: 0in; mso-bidi-language: GU;">Several well-known medications have been flagged by CDSCO, following random monthly testing by state drug officers. CDSCO is the sole authority that grants no-objection certificates to pharmaceutical companies that manufacture drugs that are unapproved, new, or banned for the sole purpose of exports in India.
Issued in August, the alert revealed over 50 popular drugs failing to meet quality standards, spanning pain relievers, antibiotics, and supplements from major pharmaceutical manufacturers.
<span style="font-size: 12.0pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Calibri; mso-bidi-theme-font: minor-latin; border: none windowtext 1.0pt; mso-border-alt: none windowtext 0in; padding: 0in; mso-bidi-language: GU;">Among flagged medications are Paracetamol 500 mg tablets, the anti-diabetic drug Glimepiride, and high blood pressure medication Telma H (Telmisartan 40 mg). Acid reflux treatment Pan D and calcium supplements Shelcal C and D3 were also on the list.
<span style="font-size: 12.0pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Calibri; mso-bidi-theme-font: minor-latin; border: none windowtext 1.0pt; mso-border-alt: none windowtext 0in; padding: 0in; mso-bidi-language: GU;">Additionally, the widely prescribed antibiotic Metronidazole, produced by Hindustan Antibiotics Limited, and Shelcal, distributed by Torrent Pharmaceuticals but produced by Pure &amp; Cure Healthcare in Uttarakhand, did not meet quality standards.
<span style="font-size: 12.0pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Calibri; mso-bidi-theme-font: minor-latin; border: none windowtext 1.0pt; mso-border-alt: none windowtext 0in; padding: 0in; mso-bidi-language: GU;">&nbsp;
<span style="font-size: 12.0pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Calibri; mso-bidi-theme-font: minor-latin; border: none windowtext 1.0pt; mso-border-alt: none windowtext 0in; padding: 0in; mso-bidi-language: GU;">A Kolkata-based lab found that antibiotics Clavam 625 and Pan D, produced by Alkem Health Science, were substandard. This same lab also flagged Cepodem XP 50 dry suspension, used for treating bacterial infections in children, from Hetero as failing tests.
<span style="font-size: 12.0pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Calibri; mso-bidi-theme-font: minor-latin; border: none windowtext 1.0pt; mso-border-alt: none windowtext 0in; padding: 0in; mso-bidi-language: GU;">Further concerns were raised over Paracetamol tablets from Karnataka Antibiotics &amp; Pharmaceuticals Ltd. 
<span style="font-size: 12.0pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Calibri; mso-bidi-theme-font: minor-latin; border: none windowtext 1.0pt; mso-border-alt: none windowtext 0in; padding: 0in; mso-bidi-language: GU;">Additionally, Sun Pharma&rsquo;s Ursocol 300, a drug for dissolving gallstones, was labeled &ldquo;spurious,&rdquo; and several batches of Telmisartan, manufactured by Life Max Cancer Lab, failed to pass quality checks.
<span style="font-size: 12.0pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Calibri; mso-bidi-theme-font: minor-latin; border: none windowtext 1.0pt; mso-border-alt: none windowtext 0in; padding: 0in; mso-bidi-language: GU;">Interestingly, a non-sterile gauze roll, also made it onto the flagged list.
<span style="font-size: 12.0pt; mso-fareast-font-family: 'Times New Roman'; mso-bidi-font-family: Calibri; mso-bidi-theme-font: minor-latin; border: none windowtext 1.0pt; mso-border-alt: none windowtext 0in; padding: 0in; mso-bidi-language: GU;">Several pharmaceutical companies have denied responsibility for producing the drugs that were flagged in the CDSCO&rsquo;s quality tests. The drug regulator shared two lists: one featuring 48 drugs and another with five additional medications.
Meanwhile, the central government has amended the export policy and restricted export of specific Active Pharmaceutical Ingredients (APIs) and formulations made from these APIs.
A notification issued by Directorate General of Foreign Trade, Ministry of Commerce and Industry says that the restrictions will come into immediate effect and until further orders. It covers following APIs and formulations made from the following APIs:
<p class="MsoListParagraphCxSpFirst" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">1)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Paracetamol
<p class="MsoListParagraphCxSpMiddle" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">2)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Tinidazole
<p class="MsoListParagraphCxSpMiddle" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">3)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Metronidazole
<p class="MsoListParagraphCxSpMiddle" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">4)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Acyclovir
<p class="MsoListParagraphCxSpMiddle" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">5)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Vitamin B1
<p class="MsoListParagraphCxSpMiddle" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">6)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Vitamin B6
<p class="MsoListParagraphCxSpMiddle" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">7)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Vitamin B12
<p class="MsoListParagraphCxSpMiddle" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">8)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Progesterone
<p class="MsoListParagraphCxSpMiddle" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">9)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Chloramphenicol
<p class="MsoListParagraphCxSpMiddle" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">10)&nbsp; Erythromycin salts
<p class="MsoListParagraphCxSpMiddle" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">11)&nbsp; Neomycin
<p class="MsoListParagraphCxSpMiddle" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">12)&nbsp; Clindamycin salts
<p class="MsoListParagraphCxSpMiddle" style="mso-margin-top-alt: auto; mso-margin-bottom-alt: auto; mso-add-space: auto; text-indent: -.25in; line-height: normal; mso-list: l0 level1 lfo1; background: white;">13)&nbsp; Ornidazole
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‘Unsafe’ medications include pain relievers, antibiotics, and supplements

Centre amends export policy of certain active pharma ingredients

CDSCO flags 50 meds over quality test failure

Centre amends export policy of certain active pharma ingredients

September 26, 2024 | 18:07 IST