Indian Pharmaceutical Sector - Overview

Indian pharmaceuticals market is the third largest in the world in terms of volume. In terms of value it is ranked 13 in the world. It has the largest no. of FDA approved plants (around 500+) outside USA. The industry is expected to grow at 20% over the next 5 years. Currently, the industry is growing at 10-11%.

India made a turnaround after patents regime, by focussing on reverse engineering new process and to manufacture the same at low cost. India is still to become a player in terms of drug innovation.

The Government of India has unveiled 'Pharma Vision 2020' in 2013, to make India a global leader in drug manufacturing. It has reduced approval time for new facilities to boost investments. Further, the government has also put in place mechanisms such as the Drug

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Zydus Cadila receives USFDA approval for Exemestane tablet

Zydus Cadila has received final USFDA approval to market Exemestane tablets, used for treatment of breast cancer. The drug in the strength of 25 mg will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad. According to industry estimates, estimated sale for Exemestane tablets is USD 68.6 million per year. The company has more than 220 approvals and so far filed over 330 abbreviated new drug applications (ANDAs).

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Gujarat Medical Services Corp sets up rapid microbiological testing lab

Gujarat Medical Services Corp Ltd is setting up a microbiological testing lab which will handle and test multiple samples in two hours time. The lab is being set up with assistance from BioMérieux, a French company. Now a days, Indian pharma companies are making conscious efforts to understand what FDA investigators look for in a pharmaceutical product and API facility and how to be equipped to avoid compliance issues in terms of manufacturing and drug quality. The French company BioMerieux will also train Gujarat FDCA inspectors to audit drug quality.

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NPPA fixes drugs of 22 formulations for bacterial infections, cardiac conditions etc.,

National Pharma Pricing Authority (NPPA) has fixed the retail and ceiling prices of 22 formulations used for treatment of various ailments including HIV, bacterial infections and cardiac conditions among others. It has fixed ceiling prices of Co-trimoxazole (Sulphamethoxazole(A) and Trimethoprim(B) tablets used for treating a variety of bacterial infections and oral rehydration salt (ORS). It has also fixed the retail prices of drugs such as Omeprazole Domperidone capsule used for treatment of acidity and gastroesophageal reflux disease, Clotrimazole Beclomethasone cream used for treating variety of inflamed fungal skin infections, Rosuvastatin Clopidogrel tablet used to lower cholesterol level and triglycerides and Tenofovir Disoproxil Fumarate Lamividine Efavirenz tablet used in treatmen

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Maharashtra FDA plans microbiology test lab

Maharashtra Food and Drug Administration (FDA) is planning to set up a microbiological testing lab at Mumbai. The lab will be set up with an investment of Rs. 45 million and will have facilities to test 100 samples in a day and detect pathogenic organisms in drugs. The lab will cater to global regulatory requirements and will test for pathogens, disinfection efficacy etc.,

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Central Government plans to facilitate e-pharmacies

Central government of India intends to make amendments in Drug and Cosmetics Act to facilitate online sales of pharmaceutical products or epharmacy. Now, e-pharmacy registration can happen through Form 18AA through the online portal of the Central government along with a fee of Rs. 50,000 and the registration will be valid for a period of three years.

The amendment also seeks to bring put in place a facility for customer support and grievance redressal of all stakeholders which shall run not less than 12 hours for all seven days of a week. It also restricts e-pharmacies to advertise any pharma products. Besides, it also prohibits under the categories of the narcotic and psychotropic as referred to in the Narcotic Drugs and Psychotropic Substances Act, 1985, tranquilizers an

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CCRAS to launch drug for Dengue

Central Council for Research in Ayurvedic Sciences (CCRAS), an autonomous body under the Ministry of AYUSH and Indian Council of Medicine Research (ICMR) from Belgaum in Karnataka have developed a drug to effectively counter dengue. They have already conducted pilot studies and double blind placebo controlled clinical trials which have proved the clinical safety and efficacy of the drug. The drug contains several herbal ingredients which have mentioned in Ayurvedic medicine. As of now, there are no effective drug to counter dengue and other treatments are done to provide relief from the symptoms.

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India imposes anti-dumping duty on Ofloxacin from China

India has imposed anti-dumping duty on import of ?Ofloxacin from China. The duty on import of ?Ofloxacin? from China will be in the range of $2.58 to $9.48 per kg for three years, said a notification issued by the Revenue Department in the Finance Ministry. The levy has been slapped following the recommendations of the Directorate General of Anti-Dumping and Allied Duties (DGAD). Ofloxacin is used to treat certain infections, including bronchitis, pneumonia and infections of the skin, bladder, urinary tract, reproductive organs, and prostate (a male reproductive gland).

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ICMR and Pfizer to set up "Centre to Combat Antimicrobial Resistance"

The Indian Council of Medical Research (ICMR) and Pfizer are setting up a centre to address the growing threat of antimicrobial resistance in India. The ?Centre to Combat Antimicrobial Resistance? will come up in New Delhi . Pfizer will provide an initial grant of Rs. 67 million. The joint initiative will implement comprehensive interventions, ranging from antimicrobial resistance (AMR) stewardship programmes for nursing homes to scaling up of the ongoing AMR surveillance network and creating awareness around responsible use of antibiotics.

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India's generic drug exports reaches 22% of world production

India's generic drug exports is growing at 22% over every year. According to Pharmaexil, generic exports accounts for around 20-22 per cent of the world?s production, covering more than 60,000 brands and 60 therapeutic classes. The APIs, generics and alternative systems of medicine ? climbed to $16.84 billion during 2016-17, with 34 per cent and 15 per cent supplied to the US and EU markets respectively. India has got extensive product portfolio, which provides the capability to manage and treat any ATC (Anatomical therapy classification) ? to the same quality as the innovators ? at highly affordable costs

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