Tides of Indian pharma

Tides of Indian pharma by Levin thomas

Analysis of New Drugs approved by CDSCO for use in humans in 2017 by ATC Classification.

In the year 2017 (from 06-01-2017 to 07-12-2017), there were 37 new drugs approved by CDSCO for use in humans and for veterinary use. The current article analyses the new drugs approved for use in humans into various pharmacological categories using the globally accepted ATC classification of drugs.

As shown in graph 1, it can be analyzed that the maximum number of new drugs approved were anticancer and antiinfectives. No new drugs for musculoskeletal system, antiparasites, insecticides and repellants were approved last year.

Graph 1: No. of new drugs approved in each ATC pharmacological category in 2017.

The new drugs approved in each ATC category with their indication are as follows:

A.      Alimentary tract and metabolism

1.      Dexlansoprazole Delayed Release Capsule 30/60mg & Bulk (erosive esophagitis & GERD)

2.      Prucalopride 1mg/2mg Tablet (chronic idiopathic constipation)

3.      Eliglustat 84mg Capsules ( Gaucher disease type 1 )

B.     Blood and blood forming organs

1.      Argatroban Hydrate Bulk & Injection 250 mg/2.5 ml (Heparin induced thrombocytopenia (HIT))

C.     Cardiovascular system

1.      Efonidipine Hydrochloride Ethanolate Bulk & Tablets 10 mg/20mg/40mg (Hypertension & Angina)

2.      Macitentan Bulk and Tablets 10 mg (Pulmonary arterial hypertension (PAH)

D.      Dermatologicals

1.      Apremilast bulk & film coated tablets 10 mg/20 mg/30 mg (Psoriasis)

  G. Genito urinary system and sex hormones

1.      Mirabegron Prolonged Release Tablet 25 mg /50 mg (Urinary incontinence/ Urgency)

2.      Etonogestrel 68 mg implant (For use by women to prevent pregnancy)

3.      Dienogest 2mg Tablets  (For the management of Pelvic pain associated with Endometriosis )

H. Systemic hormonal preparations, excl. sex hormones and insulins

1.      Pasireotide long-acting release 20/40/60mg powder (Acromegaly )

J. Antiinfectives for systemic use

1.      Delamanid 50 mg tablet (MDR TB)

2.      Arbekacin bulk & Injection 200mg/4ml (Methicillin resistant Staphylococcus aureus (MRSA) infections)

3.      Arteolane Maleate and Piperaquine phosphate Dispersible tablets (37.5 mg +187.5 mg (Plasmodium falciparum malaria infection)

4.      Sofosbuvir 400 mg +Velpatasvir 100 mg Tablet (Chronic Hepatitis C )

5.      Tenofovir Alafenamide Fumarate bulk & 25 mg capsules (Chronic Hepatitis B virus infection)

L. Antineoplastic and immunomodulating agents

1.      Carfilzomib Sterile Lyophilized Powder for Injection 60mg/vial (50ml vial) ( Multiple myeloma)

2.      Dabrafenib 50mg/75mg Capsules (Metastatic melanoma)

3.      Trametinib 0.5mg/2mg Tablets (Metastatic melanoma)

4.      Alectinib 150mg Capsules (metastatic non-small cell lung cancer (NSCLC))

5.      Osimertinib 40 mg/80 mg Film coated Tablets (non-small cell lung cancer (NSCLC))

6.      Ribociclib 200 mg Film coated Tablets (Metastatic breast cancer)

7.      Midostaurin 25 mg Capsules (AML)

8.      Teriflunomide  14 mg tablets (Multiple sclerosis)

9.      Pomalidomide 1mg/2mg/3mg/4mg Capsules (Multiple myeloma)

10.  Treosulfan Bulk & injection 5g/vial (Haematopoetic stem-cell transplantation)

  M. Musculo-skeletal system: Nil

   N. Nervous system

1.      Brivaracetam Film Coated Tablets 50mg/75mg/100mg (Epilepsy)

  P. Antiparasitic products, insecticides and repellents : Nil

  R. Respiratory system

1.      Fluticasone Furoate (100 mg mcg) and Vilanterol Trifenatate (25 mcg) powder for inhalation (COPD)

2.      Bepotastine Besilate 10 mg Tablets (Allergic rhinitis)

  S. Sensory organs

1.      Bepotastine Besilate 1.5 %w/v Ophthalmic solution (Allergic conjunctivitis)        

  V. Various: Nil