Rapid growth of pharma
India pharma industry has grown from $6b to $26b in 11yrs (see link1). It is set to grow at double digits (15% till 2020) to reach $55b. It has 20% of worlds exports by volume. Global markets are less buoyant (5%pa) and are affected by tighter drug laws (US FDA) and intense competition. Indian firms are cost-effective, have competent tech expertise, are increasing R& D spend (11% sales now) and expanding in emerging markets (like LAm, Russia).
Global practices to become a global hub
Most Indian pharma firms are adding significant capacity, thanks to fast clearances of projects and govt actions. Many are aiming to become dominant global suppliers (see link 2). Govt is facilitating fast approvals until new regulations are in place. Firms are demanding global best practices for not only cheaper and shorter development cycles but to meet global approvals for their product quality and manufacture.
Govt had earlier sped up drug approvals by creating online processing, monthly review meetings and better training for experts. New regulations are set to reduce layers of approvals, through research design protocols will become stringent. The aim is to shorten approvals by extra 30-40% to 4-6mo (see link 3). Licences for manufacture, marketing and facilities of medicines, drugs and medical devices, will be lengthened or made perpetual. New drugs policy will enforce WHO standards of manufacturing backed by licence compliance visits (see link 4).
Challenges
1. Nontrade barriers or market access denied
2. Price controls discouraging investment
3. Innovation to be promoted
4. Centres of Excellence
5. Active ingredients: dependency on China
1. Trade policy: China and Japan have created high walls - difficult to pierce Chinese distribution companies or lengthy Japanese waits. Foreign trade policy wants: tracking and tracing by barcodes at 3 stages; branding; and trade promotion (see link 5).
2. Price control: NITI Aayog wants to reduce listings under essential drugs by asking for wider consultations, and for softer controls (or negotiated prices) for essential drugs (see link 6). Action: 100 drugs de-listed and 10% price increase accepted (see link 7), but govt has actually listed many more, from 684 to 875.
3. Innovation: GOI's multi-billion PPP innovation fund for investment in new ventures aims to discover 1 in 5-10 drugs in India (see link 8). The earlier policy provided for tax incentives for R&D, 100% FDI, pharma parks for cluster benefits, easier registration of IPR, ease of doing business and higher public research spend.
4. Centres of Excellence can provide a critical mass of quality researchers. Academia and industry will cooperate for tailored courses, industry access and inputs and jobs scheme. Govt's NIPER (education and research institute) has signed 17 firms till 2015. Govt gives grants for infra and capacity building. Industry may contribute via a tax on IP revenues (see link 9).
5. Active Ingredients: Bulk Drugs, forming 25% of total business is a rapidly growing sector, but 85% of technology is imported. Problematic dependency on China and a steady loss of export business are chief concerns.
Biologic market
https://plus.google.com/u/0/100789863972538583352/posts/U1xQHpTYd8L
PM Jan Aushadhi scheme (generic medicines)
https://plus.google.com/u/0/100789863972538583352/posts/4sZ3uBrQnsY
Active Ingredients import substitution
https://plus.google.com/u/0/100789863972538583352/posts/NRqKaNLqgDu
Pharma | Exciting possibilities ahead
India pharma industry has grown from $6b to $26b in 11yrs (see link1). It is set to grow at double digits (15% till 2020) to reach $55b. It has 20% of worlds exports by volume. Global markets are less buoyant (5%pa) and are affected by tighter drug laws (US FDA) and intense competition. Indian firms are cost-effective, have competent tech expertise, are increasing R& D spend (11% sales now) and expanding in emerging markets (like LAm, Russia).
Global practices to become a global hub
Most Indian pharma firms are adding significant capacity, thanks to fast clearances of projects and govt actions. Many are aiming to become dominant global suppliers (see link 2). Govt is facilitating fast approvals until new regulations are in place. Firms are demanding global best practices for not only cheaper and shorter development cycles but to meet global approvals for their product quality and manufacture.
Govt had earlier sped up drug approvals by creating online processing, monthly review meetings and better training for experts. New regulations are set to reduce layers of approvals, through research design protocols will become stringent. The aim is to shorten approvals by extra 30-40% to 4-6mo (see link 3). Licences for manufacture, marketing and facilities of medicines, drugs and medical devices, will be lengthened or made perpetual. New drugs policy will enforce WHO standards of manufacturing backed by licence compliance visits (see link 4).
Challenges
1. Nontrade barriers or market access denied
2. Price controls discouraging investment
3. Innovation to be promoted
4. Centres of Excellence
5. Active ingredients: dependency on China
1. Trade policy: China and Japan have created high walls - difficult to pierce Chinese distribution companies or lengthy Japanese waits. Foreign trade policy wants: tracking and tracing by barcodes at 3 stages; branding; and trade promotion (see link 5).
2. Price control: NITI Aayog wants to reduce listings under essential drugs by asking for wider consultations, and for softer controls (or negotiated prices) for essential drugs (see link 6). Action: 100 drugs de-listed and 10% price increase accepted (see link 7), but govt has actually listed many more, from 684 to 875.
3. Innovation: GOI's multi-billion PPP innovation fund for investment in new ventures aims to discover 1 in 5-10 drugs in India (see link 8). The earlier policy provided for tax incentives for R&D, 100% FDI, pharma parks for cluster benefits, easier registration of IPR, ease of doing business and higher public research spend.
4. Centres of Excellence can provide a critical mass of quality researchers. Academia and industry will cooperate for tailored courses, industry access and inputs and jobs scheme. Govt's NIPER (education and research institute) has signed 17 firms till 2015. Govt gives grants for infra and capacity building. Industry may contribute via a tax on IP revenues (see link 9).
5. Active Ingredients: Bulk Drugs, forming 25% of total business is a rapidly growing sector, but 85% of technology is imported. Problematic dependency on China and a steady loss of export business are chief concerns.
Biologic market
https://plus.google.com/u/0/100789863972538583352/posts/U1xQHpTYd8L
PM Jan Aushadhi scheme (generic medicines)
https://plus.google.com/u/0/100789863972538583352/posts/4sZ3uBrQnsY
Active Ingredients import substitution
https://plus.google.com/u/0/100789863972538583352/posts/NRqKaNLqgDu
Pharma | Exciting possibilities ahead
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