Alkem faces charge of clinical study data manipulation

The European Medicines Agency (EMA) is reviewing some drugs following a red flag over their clinical trial studies, which were conducted by Mumbai-based Alkem Laboratories.
The review of the drugs, that include antibiotics cefuroxime and rulizole, used to treat neurological disorder amyotrophic lateral sclerosis and sold both by Alkem and Slovenia's Krka, has been ordered after German drug regulator's raised concerns over trial study data.
Alkem conducted trials on the drugs at its Taloja facility in Maharashtra for Krka.
In a notice, EMA said, "This follows a good clinical practice (GCP) inspection of this site which raised concerns regarding study data used to support the marketing authorisation applications of some medicines in the EU."

There was no immediate comment from the company over the allegations.
The inspection was carried out jointly by the German and Dutch authorities in March 2015 in the context of a routine evaluation of applications for nationally authorised medicines, it added.

"Having considered the inspection findings, the German medicines agency (BfArM) has requested EMA to assess the impact that these findings may have on the benefit-risk of medicines authorised in the EU on the basis of studies performed at this site," the EU health regulator said.
BfArM has requested EMA to look at the impact on medicines which are currently being evaluated for authorisation purposes and which use study data from the site, it added.

"The agency (EMA) will now determine which medicines are concerned and will review the available data to determine whether any action is necessary to protect public health," it said.
The review is being carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which will adopt an opinion.
The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
EMA had earlier recommended suspension of about 700 pharmaceutical forms and strength of medicines for which authorisation in the EU was primarily based on clinical studies conducted at GVK Biosciences at Hyderabad.

After the instruction of EU for withdrawal of these 700 products, the government had at that time temporarily deferred resumption of the talks on free trade agreement with EU.