Olive Healthcare faces legal action over violations
Olive Healthcare was found to be manufacturing enclomiphene, a drug that is approved neither in India nor elsewhere
New Delhi: Drug regulators across Monday and Tuesday raided the Daman factory of Olive Healthcare Ltd and seized drugs not approved for manufacture, two people aware of the development said.
The Central Drugs Standard Control Organization (CDSCO) may initiate legal action against Olive Healthcare for various violations, the people cited above said.
The firm was found to be manufacturing enclomiphene, a drug that is approved neither in India nor elsewhere, one of the persons cited above said.
“As safety and efficacy of this drug (enclomiphene) is not proven, it is a great risk to patients’ health,” said one of the persons cited above.
According to the people mentioned above, Olive Healthcare manufactures enclomiphene, an estrogen receptor antagonist to treat testosterone deficiency in men; ulipsristal, a medication for emergency birth control and uterine fibroids; cetilistat, a drug to treat obesity; and dinogest for management of pelvic pain associated with endometriosis. All these drugs were found to be manufactured without permission.
During the raid, the company was also found to be procuring unapproved active pharmaceutical ingredients (APIs) illegally.
Drugmakers need approval from the Drug Controller General of India (DCGI) before launching any product.
Violations under the Drugs and Cosmetics Act and rules relate to making drugs without approval for human use, putting patients’ health at risk and using bulk drugs not meant for human use for commercial purposes. According to Section 18 (c) of the D&C Act, penalty for violation is 3-5 years imprisonment and Rs1 lakh fine.
The firm had sought approval of enclomiphene and cetilistat. “However, due to lack of safety and efficacy data same were rejected in February 2015,” said the CDSCO report, following the raids. Mint has seen a copy of the report.
It was observed during the raid that the company was manufacturing products even before applying to CDSCO and despite the rejection of its application. “The said manufacturer continued to manufacture the drug and marketed it in collusion with the marketing firms,” added the notice.
According to the second of the two persons earlier mentioned, even APIs for enclomiphene manufactured and sold by a Bengaluru-based firm was not approved. “The company producing the APIs was manufacturing it under the ‘test licence’ which means they can’t use it for commercial purpose,” said the first person.
The authorities seized 46 batches of enclomiphene, with each batch containing around 3 lakh tablets, this person said. Around 7-8 kg of raw material is still available at the site, hye added.
CDSCO has already directed the company to recall the products from the market immediately. “The ministry of health and family welfare may also take up the matter with the Daman administration,” said the second person cited above.
When contacted, Olive Healthcare denied any wrongdoing and said that the raids were normal audit check by the regulators. “This is just a rumour,” an Olive Heathcare spokesperson replied to an email sent by Mint.
According to the information available on its website Olive Healthcare manufactures more than 150 different formulations in all dosage forms.
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