1. Initiatives by GoI to Improve Quality & Global Compliance to Boost Indian Pharma Exports
EVOLUTION OF PHARMACEUTICAL PACKAGING
InnoPack Pharma Confex 2018 Presentation by
Daara B. Patel Secretary General INDIAN DRUG MANUFACTURERS’ ASSOCIATION

2. Pharmaceutical Packaging
Packaging assumes greater significance when it comes to highly regulated Pharmaceutical Market.
World over there have been many Packaging Innovations.
India exports more than half of its pharmaceutical produce to regulated, semi-regulated and third world countries.
Packaging Innovation is one of the major requirements to boost India’s Pharma Exports.
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3. India’s Pharma Exports
Indian Pharma Sector Revenue for FY2017 is approx. US$ 32 billion, with exports worth US$ 16.8 billion
Exports expected to reach US$ 40 billion by 2020.
Indian Pharma Packaging accounts for 7% of the total revenue
Indian drugs are exported to more than 200 countries in the world, with the US as the key market
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4. India’s Pharma Exports
India’s US$ 16.8 billion pharma exports in :
American continent = 40.6 %
Europe = 19.7 %
Africa = 19.1 %
Asian countries = 18.8 %
Indian companies received 304 Abbreviated New Drug Application (ANDA) approvals from the USFDA in 2017.
India accounts for around 30 per cent (by volume) and about 10 per cent (value) in the US$ billion US generics market.
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5. GOVT. OF INDIA INITIATIVES
Research and development:
Indian Government invited multi-billion dollar investment with 50 per cent public funding through its public private partnership (PPP)
Indian pharma companies spend 8-13 % of their total turnover on R&D.
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6. GOVT. OF INDIA INITIATIVES
Investments:
FDI Policy now allows 100% FDI through automatic route in Greenfield pharmaceuticals.
In Brownfield pharmaceuticals 74% FDI is allowed through automatic route and beyond 74% through GoI approval.
‘Non-compete’ clause not allowed in automatic or government approval route except in special circumstances with Government approval
FDI in Brownfield pharmaceuticals, under both automatic and government approval routes, is further subject to maintaining production level of NLEM drugs, no repatriation of employees, R&D expenditure to be maintained for 5 years in value terms etc
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7. GOVT. OF INDIA INITIATIVES
Policy Initiatives:
In March 2018, the Drug Controller General of India (DCGI) announced its plans to start a single-window facility to provide consents, approvals and other information.
This has commenced through SUGAM online portal of CDSCO. The move is aimed at giving a push to the Make in India initiative.
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8. GOVT. OF INDIA INITIATIVES
Policy Initiatives:
National Health Policy 2017:
Focuses on increasing public expenditure on healthcare segment
Plans to set up new pharmaceutical education and research institutes (NIPERs)
Exemptions to drugs manufactured through indigenous R&D & patented in India, from price control under NPPP-2012
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9. GOVT. OF INDIA INITIATIVES
Policy Initiatives:
Department of Pharmaceuticals through PPDS (Pharmaceutical Promotion Development Scheme) encourages quality upgradation of the industry.
PTUS – Pharma Technology Upgradation Scheme
IDMA has been in the forefront in imparting quality education and training to pharma manufacturers by conducting joint seminars continuously for the last 3 years in almost all manufacturing hubs in India by utilizing grants-in-aid from DoP.
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10. ROBUST GROWTH IN BIOTECH INDUSTRY
Biotechnology Industry Research Assistance Council: BIRAC has been established by Department of Biotechnology, to promote research & innovation capabilities in India’s biotech industry.
The council will provide funding to biotech companies for technology & product development.
Growing at a faster pace, in comparison with the previous years, the Indian biotech industry witnessed YoY growth of per cent in FY16; the total industry size stood at US$ 11 billion by FY16 and is estimated to have reached US$ 11.6 billion in FY17.
The Indian biotech industry comprises of around 800 companies. In order to achieve market size of US$ 100 billion by 2025, the industry has requested Government of India to invest US$ 5 billion to initiate research activities and develop infrastructure as well as human capital.
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11. ROBUST GROWTH IN BIOTECH INDUSTRY
India biotech start-ups attracted investments worth US$ 2.8 billion between 2012 and February 2017.
In May 2017, the Department of Biotechnology held a strategy meet in Delhi to discuss the future scenario of the Biotechnology industry in the country.
The meet highlighted the aim of reaching US$100 billion mark by 2025, research and development of cutting edge technologies and other important aspects.
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12. Pharmaceutical Packaging
Role of pharmaceutical packaging primarily is to provide containment, protection, presentation and information, identification and convenience.
Today requirements of packaging are extended to cover criteria like stability & shelf life, patient compliance, prevention of product tampering & counterfeiting, preserving brand identity etc.
To meet these requirements packaging industry has developed innovative and sophisticated concepts, which we will discuss shortly.
Pharma companies have started embracing packaging innovations for effective brand building, improve patient adherence, protect Brands, etc.
Final Point of Contact between patients and healthcare providers is not the dispensing pharmacist, but the pharma package.
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13. Evolution of Pharma Packaging
In 16th century, most of the medicines were liquid or semisolid which was stored in delftware. It was decorated with blue and white colored painting of cherub motif and was used commonly by chemist and pharmacist.
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14. Evolution of Pharma Packaging
In the earlier 17th century cream-ware manufactured from creamy colored lead-glazed earth-ware which were light in weight. Cream-ware were widely used in British pharmacies for almost every form of medicine containers.  
The most incredible were the leech jars having pierced lids to allow leeches to breathe.
In Europe, pharmacies used big wooden cylindrical containers to preserve dried botanical drugs and chemicals along with tightly fitted lids to prevent it from atmospheric moisture.
Pewter (ductile metal alloy) vessels were also used to store medicinal oils and ointments.
Pharmaceutical prescription labels were gracefully engraved on silver or other light material plaque, which were tied with a short chain or metal ring to the neck of the vessel containing the drug.
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15. Evolution of Pharma Packaging
In 18th century, glass bottles with wooden or glass stoppers and tin containers were more commonly used for storing drugs.
Art of label printing was at its peak in this century.
Lithography (painting on stone with oily ink) was initiated and with the passage of time it became more sophisticated and upgraded to chromo-lithography.
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16. Evolution of Pharma Packaging
In 19th century Remington familiarized the first commercially available typewriter for label printing.
Simultaneously, the automatic bottle blowing machine with customized embossed letters for drug names was invented.
Colored glass bottles were used in order to prevent some drugs from the unsafe effect of light.
During World War II in 20th century, many researches were conducted in order to use light weight and unbreakable containers for shipping medicines to the armed forces.
This resulted in Plastic pharmaceutical containers.
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17. Evolution of Pharma Packaging
Present Day Packages for Various Formulations:
Ampoules for Aqueous or Non-aqueous Injectables
Vials for Aqueous or Non-aqueous Injectables or dry powders for parenteral use
Bottles & Jars for Oral solids like tablets, capsules, oral liquids, nasal & ear drops, blood & related products.
Droppers as Auxiliary Packaging Device
Aerosol Containers for Aerosol product ( solution, suspension, emulsion or semisolid type)
Strips & Blister Packs used for Tablets & Capsules
Collapsible Tubes for Ointments, creams, gels & other semisolids
Cans for Aerosols, inhalers, sprays etc.
Sachets
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18. Packaging Innovations Influences Impacting Packaging
Dispensing of product
Compliance
Communication of information—labeling
Tamper evidence
Radio frequency identification (RFID)
Anticounterfeiting measures
Environmental issues
Unit-dose packaging
Administration aids
Child Resistant & Seniors Friendly Packaging
Growth of the elderly population worldwide
Generic drugs
Self-medication
Product branding
Graphic development (labeling) changes in pharmaceutical communication
Enterprise content management
Digital asset management
Direct to consumer advertising
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19. Recent Packaging Technologies
Blow-fill-seal technology
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20. Recent Packaging Technologies
Anti-Counterfeiting Technology Solutions:
Overt (visible) features: Tamper evident packaging systems
Covert (hidden) features
RFID: (Radio Frequency Identification)
Packaging Designs
Security labels
Coding, printing and graphics
Holograms
Forensic markers
Mass encoding / Track & Trace technologies
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21. Packaging Innovations
Patient Compliance:
Pre-filled Syringe
Metered Multi-dose pens
Multi Dose Inhalers
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22. Packaging Innovations
Child-Resistant & Senior-Friendly Packaging
"Any CR packaging worth its salt must be as easy for a grandparent to open as it is difficult for their grandchild."
CR Blister Pack uses a pressure point locking system that allows easy access for elderly users while keeping kids out
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