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Gujarat, the pharma hub

In the next 10 years, Gujarat pharmaceutical industry is expected to see a CAGR of 15-20%. The State, a hub for both national and international pharma companies – Sun pharma, Alembic, Torrent, Novartis, Cadila… offers a huge market for mechanised cleaning.

Valued currently at around 72,069Cr against 65, 654cr in 2012, Indian Pharmaceutical Industry is predicted to be among the top 10 markets in the world by 2020. Along with healthcare and hotels, pharma sector too has a huge market for mechanised cleaning. Professional cleaning of pharma facilities is mandatory to obtain the necessary compliances. There have been instances where licenses and export have been banned owing to the substandard cleaning and hygiene. Very recently, the US has banned import from Sun Pharmaceuticals’ Gujarat plants.

Gujarat houses units manufacturing a range of diverse products that include tablets, capsules, dry syrups, external preparations, cytotoxic drugs, vaccines, small and large Volume Parenteral Solutions, APIs, biopharma products and medical devices. Having four percent of the nation’s population, Gujarat has been the Mecca of India Pharmaceuticals market where almost all the big companies have their presence, producing 40% of the country’s medicines. In the recent global investors summit concluded in 2013, foreign players are foraying to the State. US-based Abbott Laboratories, Israel’s Teva Pharmaceutical and Singapore-based Biosensors International have already planned to set up their plants in Gujarat.

Positive trend

Gujarat offers investment-friendly policies such as easy availability of labour and land. However there is a pressing need for good clinical guidelines. The industry wants all the documentation procedures online so that manufacturers can focus on their business rather than waste time in handling paperwork and bureaucracy.

“Gujarat has 3,637 licensed units engaged in this industry. Of these, nearly 800 are active in direct manufacturing of drugs. Only 20% of these are medium or major manufacturers while 80% are small-scale units. These include 384 units approved by the World Health Organisation’s Good Manufacturing Practice Certification (WHO-GMP), and 29 units approved by the United States Food and Drug Administration (USFDA). Besides, there are other 2,538 allopathic units, 712 Ayurvedic, 14 homoeopathic and 373 cosmetics. Gujarat has over 1,100 formulation units and 400 bulk drug manufacturing units,” reports The Hindu. Further, “Gujarat has also seen a 40% growth in contract manufacturing as well as in API industry and 60% in formulation. With 1,361 drugs going off-patent in 2011, generic and other segments are expected to grow exponentially. About 75,000 people are employed in Gujarat’s pharmaceutical industry.”

With six pharamceuical SEZs, and 90 pharmacy colleges, the state homes entire industry in and around Ahmedabad, Vadodara, Ankleshwar and Bhavnagar. Many, out of 300 pharma companies those had migrated or set up plants in incentive-providing states such as Uttarakhand, Sikkim and Himachal Pradesh are now returning to Gujarat as the 10-year tax holiday period is coming to an end. Apart from the incentive, there were issues such as Power, water shortage, lack of skilled staff and transportation. This is why when other pharma centric states like Andhra Pradesh and Tamil Nadu registered a dip 6.2% and 5.2% negative growth, respectively. Gujarat based pharma companies could register a moderate 3.6% growth.

The Chinese president’s recent visit has had positive results for Pharma sector as well. President, Xi promised that Indian pharmaceutical industries would be given greater access to Chinese markets, in a bid to bridge the yawning trade deficit between the two countries. As per the Vibrant Gujarat report, the proprosed investment in Sanand in pharma sector stands at US $0.0068 billion.
In the 2013 Vibrant Gujarat Summit, over 130 pharma companies were recognised for its investment plans. Some of the companies are:

• Aban Pharmac Euilcals
• Apollo Pharmaceuticals,
• Accretion Pharmaceuticals
• Ayukalp UAP pharma pvt ltd
• Cure & Care Pharma
• K.C Son Pharma Machinery
• Manish Pharma Lab
• Nisha Pharma
• Pharmatech Healthcare
• Shreeji Pharmatech
• Stanmark Pharmaceuticals
• Star Pharmaceuticals
• Sunij Pharma Pvt Ltd
• Swiss Pharmaceuticals
• Toton Pharamceuticals
• Vigro UAP Pharma
• Zillion Pharma

[box type=”shadow” align=”aligncenter” ]Gujarat Pharmaceuticals • Global demand for generics rising • Rapid OTC and generic market growth • Increased penetration in non-metro markets • Large demand of quality diagnostic services • Significant investment from MNCs • Public Private Partnership (PPP) for strengthening infrastructure[/box]

• Causeway Pharma
• Jenburkt Pharmaceuticals Ltd
• Prince Care Pharma Pvt Ltd

• Sharma Pharmaceuticals Pvt Ltd
• Shree Rang Pharmachem
• Green Healthcare
• Cadila Healthcare
• Radiant Parentrals Ltd
• Sun Pharmaceutical Industries Limited

Investments by other companies
• G A Pharmaceutical, Surat
• Adani Pharmachem Pvt Ltd, Rajkot
• Adlac Lifescience Pvt Ltd, Gandhinagar
• Ajanta Pharma,
• Alembic Pharmaceuticals Ltd, Halol
• Alkem Laboratories Ltd, Bharuch
• Aryan Pharma, Mehsana
• Glenmark Generics Ltd, Bharuch
• J.B. Chemicals & Pharmaceuticals Ltd, Ankleshwar

In order to avail the right medicine to the end consumer is as important as production of the same based on necessary compliances. This opens a huge opportunity for the cleaning industry in pharmaceuticals.

[box type=”shadow” align=”aligncenter” ]Cleaning methods: Common cleaning equipments used for physical removal of dust and dirt are vacuum cleaners, brooms, brushes, floor mops, sponges and jet cleaners. Cleaning agents help to remove extraneous material from surfaces.

Cleaning agents used are: Active ingredients Concentration Uses Teepol Sodium benzene sulphate, alcohol ether sulphate and alcohol ethoxylate 0.1% Multipurpose cleaning agent, can be used for equipment, floors, glasswares Avipol Liquid detergent of the sodium alkyl sulphate type 1% Tanks and vessels in liquid oral manufacturing. Liquid Soap ‘as is’ Can be used for washing hands gloves, machine parts. Vim Mixture of detergents ‘as is’ Toilets, floors, sinks.

Disinfectants used: Disinfectants destroy pathogenic and other microorganisms and are used to reduce the microbial count in the manufacturing area. Commonly used disinfectants, their chemical nature and uses are given here under: Name of the disinfectant Active ingredients Uses Savlon Chlorhexidine gluconate and cetrimide 2.5% solution can be used for treating all surfaces in aseptic area. Dettol Chlorxylenol and terpineol 2.5% solution can be used for hands & spray Fairgenol Dichlormetaxylenol, terpineol & soap 2.5% solution can be used for treating all surfaces in aseptic area.

– Anupama Katte
M. Pharma, Gyan Vihar University [/box]

GMP Compliances

More than 70% of Gujarat companies are US-FDA and EU-GMP compliant, essential to export. The EU-GMP or US-FDA have set standards for all the steps right from clean room classification, monitoring, technologies, personnel, premises, equipment, sanitation, processing, sterilisation methods and aseptical Filling. Clean rooms have been classified in accordance with EN ISO 14644.

Further, hygiene, clothing and training too are the basic elements for maintaining clean rooms. The clean rooms where formulations are carried out are under constant monitoring. Any cracks or holes must be filled and disinfected immediately. This can have a direct impact on processing and product quality.

Among the other essential and regular services are maintenance of HVAC, dust extraction, drainage and micro-organism limits at work areas. Pest management too are carried out in a very controlled approach.

Suprita Anupam

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