Alkem

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On 23 June 2016, the European Medicines Agency (EMA) recommended the suspension of a medicine (Riluzole Alkem), for which studies were conducted at the Alkem Laboratories Ltd site in Taloja, India, and has required companies to provide new data for another medicine before it can be authorised in the EU.

The recommendations followed a joint routine inspection by German and Dutch authorities in March 2015, which revealed misrepresentation of data during the conduct of two different trials performed in 2013 and 2014 at the Taloja site. The findings cast doubts on the quality management system in place at the site, and thus on the reliability of the data of bioequivalence studies conducted between March 2013 and March 2015.

EMA’s Committee for Medicinal Products for Human Use (CHMP) noted that, although there is no evidence of harm or lack of effectiveness linked to the conduct of studies by Alkem Laboratories Ltd, the studies cannot be accepted in marketing authorisation applications in the EU. Therefore, the Committee recommended that medicines authorised or being evaluated on the basis of these studies should be suspended or refused authorisation, unless alternative data are available from other sources.
The specific recommendations of the CHMP are as follows:

  • Riluzole Alkem, a medicine for amyotrophic lateral sclerosis (ALS) which has yet to be marketed in the EU, should now be suspended.
  • Ibuprofen Orion, a painkiller currently under evaluation by national authorities, cannot be authorised on the basis of studies carried out at Alkem Laboratories Ltd. So far no alternative studies from other sources have been provided
  • Cefuroxime Ingen Pharma, currently under evaluation by national authorities, can still be considered for authorisation, as studies from other sources have been provided.
  • Cefuroxime Alkem and Cefuroxime Krka (antibiotics) can remain on the market in the EU, as alternative studies have been provided that support a positive benefit-risk balance.

The CHMP’s recommendations concerning these medicines were sent to the European Commission, which issued a legally binding decision valid throughout the EU.

EMA will continue to work closely with national authorities and international partners to ensure that studies underpinning marketing authorisations in the EU are carried out to the highest standards and that companies continue to comply fully with all aspects of Good Clinical Practice (GCP).

Information for patients and for healthcare professionals

Some studies carried out at the Alkem Laboratories Ltd site have been found to be flawed. As a result, a medicine is being suspended. Medicines under evaluation cannot be granted authorisation on the basis of these studies; further data would have to be provided to support authorisation.

  • The medicine being suspended, Riluzole Alkem, contains riluzole and is not yet on the market in the EU. Its suspension is therefore not expected to have any impact on patients in the EU. Other riluzole-containing medicines remain available.
  • There is no evidence of harm or lack of effectiveness with any of the medicines linked to studies conducted by Alkem Laboratories Ltd.
  • Patients should continue to take their medicines as prescribed.
More about the medicines

The review covered medicines authorised via national procedures in individual EU Member States, whose marketing authorisation applications included data from studies conducted by Alkem Laboratories Ltd, Department of Bioequivalence, C-17/7, MIDC Industrial Estate, Taloja, Dist. Raigad - 410208 India. It also included ongoing marketing authorisation applications for medicines which use study data from the site.

More about the procedure

The review of Alkem was initiated on 1 April 2016 at the request of the German medicines authority (BfArM), under Article 31 of Directive 2001/83/EC.

The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency’s opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 8 September 2016.

Name Language First published Last updated
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU BG = bălgarski 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU ES = español 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU CS = čeština 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU DA = dansk 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU DE = Deutsch 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU ET = eesti keel 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU EL = elliniká 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU EN = English 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU FR = français 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU IT = italiano 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU LV = latviešu valoda 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU LT = lietuvių kalba 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU HU = magyar 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU MT = Malti 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU NL = Nederlands 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU PL = polski 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU PT = português 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU RO = română 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU SK = slovenčina 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU SL = slovenščina 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU FI = suomi 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU SV = svenska 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU HR = Hrvatski 2016-06-24 2016-10-07

Key facts

Approved nameAlkem
International non-proprietary name (INN) or common name
Associated names
Class
Reference numberEMEA/H/A-31/1436
TypeArticle 31 referrals

This type of referral is triggered when the interest of the Community is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

StatusEuropean Commission final decision
Opinion date23/06/2016

All documents

Name Language First published Last updated
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU BG = bălgarski 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU ES = español 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU CS = čeština 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU DA = dansk 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU DE = Deutsch 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU ET = eesti keel 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU EL = elliniká 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU EN = English 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU FR = français 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU IT = italiano 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU LV = latviešu valoda 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU LT = lietuvių kalba 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU HU = magyar 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU MT = Malti 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU NL = Nederlands 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU PL = polski 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU PT = português 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU RO = română 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU SK = slovenčina 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU SL = slovenščina 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU FI = suomi 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU SV = svenska 2016-06-24 2016-10-07
Alkem Article-31 referral - Studies from Alkem Laboratories Ltd cannot be used to support medicines approval in the EU HR = Hrvatski 2016-06-24 2016-10-07
Alkem Article-31 referral - Annex I BG = bălgarski 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I ES = español 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I CS = čeština 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I DA = dansk 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I DE = Deutsch 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I ET = eesti keel 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I EL = elliniká 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I EN = English 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I FR = français 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I IT = italiano 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I LV = latviešu valoda 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I LT = lietuvių kalba 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I HU = magyar 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I MT = Malti 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I NL = Nederlands 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I PL = polski 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I PT = português 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I RO = română 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I SK = slovenčina 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I SL = slovenščina 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I FI = suomi 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I SV = svenska 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex I HR = Hrvatski 2016-04-01 2016-10-07
Alkem Article-31 referral - Annex II BG = bălgarski 2016-10-07  
Alkem Article-31 referral - Annex II ES = español 2016-10-07  
Alkem Article-31 referral - Annex II CS = čeština 2016-10-07  
Alkem Article-31 referral - Annex II DA = dansk 2016-10-07  
Alkem Article-31 referral - Annex II DE = Deutsch 2016-10-07  
Alkem Article-31 referral - Annex II ET = eesti keel 2016-10-07  
Alkem Article-31 referral - Annex II EL = elliniká 2016-10-07  
Alkem Article-31 referral - Annex II EN = English 2016-10-07  
Alkem Article-31 referral - Annex II FR = français 2016-10-07  
Alkem Article-31 referral - Annex II IT = italiano 2016-10-07  
Alkem Article-31 referral - Annex II LV = latviešu valoda 2016-10-07  
Alkem Article-31 referral - Annex II LT = lietuvių kalba 2016-10-07  
Alkem Article-31 referral - Annex II HU = magyar 2016-10-07  
Alkem Article-31 referral - Annex II MT = Malti 2016-10-07  
Alkem Article-31 referral - Annex II NL = Nederlands 2016-10-07  
Alkem Article-31 referral - Annex II PL = polski 2016-10-07  
Alkem Article-31 referral - Annex II PT = português 2016-10-07  
Alkem Article-31 referral - Annex II RO = română 2016-10-07  
Alkem Article-31 referral - Annex II SK = slovenčina 2016-10-07  
Alkem Article-31 referral - Annex II SL = slovenščina 2016-10-07  
Alkem Article-31 referral - Annex II SV = svenska 2016-10-07  
Alkem Article-31 referral - Annex II HR = Hrvatski 2016-10-07  
Alkem Article-31 referral - Annex III BG = bălgarski 2016-10-07  
Alkem Article-31 referral - Annex III ES = español 2016-10-07  
Alkem Article-31 referral - Annex III CS = čeština 2016-10-07  
Alkem Article-31 referral - Annex III DA = dansk 2016-10-07  
Alkem Article-31 referral - Annex III DE = Deutsch 2016-10-07  
Alkem Article-31 referral - Annex III ET = eesti keel 2016-10-07  
Alkem Article-31 referral - Annex III EL = elliniká 2016-10-07  
Alkem Article-31 referral - Annex III EN = English 2016-10-07  
Alkem Article-31 referral - Annex III FR = français 2016-10-07  
Alkem Article-31 referral - Annex III IT = italiano 2016-10-07  
Alkem Article-31 referral - Annex III LV = latviešu valoda 2016-10-07  
Alkem Article-31 referral - Annex III LT = lietuvių kalba 2016-10-07  
Alkem Article-31 referral - Annex III HU = magyar 2016-10-07  
Alkem Article-31 referral - Annex III MT = Malti 2016-10-07  
Alkem Article-31 referral - Annex III NL = Nederlands 2016-10-07  
Alkem Article-31 referral - Annex III PL = polski 2016-10-07  
Alkem Article-31 referral - Annex III PT = português 2016-10-07  
Alkem Article-31 referral - Annex III RO = română 2016-10-07  
Alkem Article-31 referral - Annex III SK = slovenčina 2016-10-07  
Alkem Article-31 referral - Annex III SL = slovenščina 2016-10-07  
Alkem Article-31 referral - Annex III FI = suomi 2016-10-07  
Alkem Article-31 referral - Annex III SV = svenska 2016-10-07  
Alkem Article-31 referral - Annex III HR = Hrvatski 2016-10-07  
Alkem Article-31 referral - Review started (English only) 2016-04-01  
Alkem Article-31 referral - CHMP List of questions to Alkem BE Centre (English only) 2016-04-01  
Alkem Article-31 referral - CHMP list of questions (English only) 2016-04-01  
Alkem Article-31 referral - Timetable for the procedure (English only) 2016-04-01  
Alkem Article-31 referral - Notification (English only) 2016-04-01  

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

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