Fig. 6.1: The authorities and agencies involved in TOT

88 Industrial Pharmacy II

Government authorities and agencies involved in TOT (Table 6.2)

Table 6.2: Describing government agencies and their functions in TOT process

Name of agency/authority Functions

Government regulatory authority Issue guidelines

(central as well as state) Regulatory inspections

Monitoring of clinical trials

Quality, efficacy, safety checking of technology

WIPO Protect intellectual property rights of both the parties

Contd.

Table 6.1: Describing functions of departments involved in TOT process

Department Functions

R&D i. Supports technical issues

ii. Resolves technical problems

iii. It would direct and train the production trial at RU.

QA i. Review documentation to check compliance with market authorisation

ii. Compile SUs documents for transfer

iii. Initiates, confirm and compare regulatory requirements of both SUs

and RUs to point out if any change is needed.

QC i. Review analytical requirement and ensure availability with instruments

ii. Mainly responsible for analytical method transfer of product.

Engineering It will review:

i. Equipment requirement

ii. Preventive maintenance and calibration impact.

It will initiate:

i. Engineering modifications

ii. Change or part purchasing

Production i. Review process instructions

ii. It will consider if there is any:

a. Safety implications

b. Impact on local SOPs

c. Training requirement of staff of both SU and RU.

Regulatory affairs i. Coordination of regulatory filing

ii. Response to regulatory inquiries

iii. Ensure the compliance with regulatory guidelines

iv. Ensure compliance with guidelines in case of any variation/change

v. Advise on timing and filing document contents

The material i. Strategic planning

management ii. Resource allocation

iii. Supply chain activities

iv. Recommends most favourable manufacturing strategy by keeping

partnership, internal capability and tax saving in consideration

The project i. Overall coordination among departments

management ii. Allocation of responsibilities to other staffs

iii. Communicate with the management

iv. Designate any other role as appropriate

Regulation of Transfer of Technology 89

6.2 PROBLEMS FACED DURING COMMERCIALISATION

Problems faced per the stages of commercialisation/TOT:

1. Problems during the technology justification and selection stage:

i. Wrong selection of technology.

ii. Cost of buying, installing, maintenance and operation is high.

iii. The technology selected is complex for understanding and implementation.

iv. Technology is not adapted to local conditions and needs extensive adaptations.

2. Problems during the planning stage:

i. SU does not fully understand RU’s need.

ii. RU’s manager is not involved in transfer planning.

iii. Less or no attention is given to software or intellectual needs.

iv. Market forecasting is wrong.

v. The objectives of RU and SU are not clear.

vi. The mechanism chosen for the implementation of technology at RU is not

appropriate.