Tides in Indian Pharma

Pharmacy students banned from animal dissection

Pharmacy students across the country will now have to stop experiments on animals. As recently, the UGC has notified a ban on dissection of animals for academic purposes at the UG and PG levels on college campuses, the PCI has directed its institutions to impose a similar ban. The PCI in its recent gazette notification dated 28-August 2014, has declared “wherever animal experimentation are prescribed in the curriculum, the required knowledge and skill should be imparted by using computer assisted modules”.  

Specification of Pharm.D Program by UGC Act, 1956

The University Grants Commission vide Notification No. F.5-1/2013 (CPP-II) dt. March, 2014 published in the Gazette of India, Part III, Section 4, No. 27 dt. July 5- July 11, 2014 has specified the Doctor of Pharmacy (Pharm.D) degree under the Pharm.D regulations, 2008 under section 22(3) of the University Grants Commission Act, 1956 at the serial number 107. 

Finally Flupenthixol+Melitracen combination banned!!

The central government has finally banned the use of the combinational drug of Flupenthixol (typical antipsychotic) and Melitracen (tricyclic antidepressant) for human use vide Gazette notification No.GSR498 (E) dated 11-07-2014, considering it’s risk for human beings and with more safer alternatives available. The combination was illegally being promoted for 2 unapproved indications- menopausal depression and depression in alcoholics and drug addicts. The use of the combination was banned in Denmark (country of origin), US, Britain, Ireland, Canada, Japan...to name a few. Drug and Cosmetic Rule 30-B bans the import and marketing of any drug for which the use is banned in the country of origin. Further as Melitracen was not individually earlier not approved in India, the combination had to undergo phase 1, 2 and 3, so as to establish its safety and efficacy. The reports of any such trials were not furnished

. More Drugs under Price Control

The National Pharmaceutical Pricing Authority (NPPA) has brought 108 more essential drugs under Drug Price Control Order, 2013 in addition to the 348 essential drugs already under price control. These newly introduced drugs belong to 8 therapeutic drugs but mainly for treating diabetes and cardiovascular diseases such as glimepiride, gliclazide, sitagliptin, voglibose, simvastatin, telmisartan etc. Consequently the diabetic and cardiac drugs are expected to become cheaper by up to 35% in India. 

Mandatory 3 parameters in Clinical Trial Applications

The Union health ministry has made it mandatory for CRO’s, clinical trial sponsors, medical institutions and other state holders involved in the conduct of clinical trials to provide information on the following 3 aspects in their clinical trial applications with immediate effect.

1. Assessment of Risk verses Benefit to patients.

 2. Innovation vis-a vis  existing therapeutic option.

 3. Unmet medical needs in the country. 

By Levin Thomas

Asst Professor

Dept of Pharmacy Practice

Alshifa college  of Pharmacy