The Compound Eye

Policy Focus

Gene Therapies - Finally! 

After nearly two years of holding a discussion on guidelines for gene editing for human interventions, ICMR has released a 100 page draft guideline for gene therapies. The document was open for public consultation for about one week and highlights the need for guidelines governing clinical trials involving gene therapies. 

The document defines a gene therapy product (GTP) as any entity which includes a nucleic acid component being delivered by various means for therapeutic benefit. This includes DNA or RNA modification through technologies like CRISPR or shRNA. The definition also include DNA vaccines as a GTP. 

The document sets an overarching structure for approval processes for gene therapies. In addition to the already existing RCGM (Review Committee on Genetic Manipulation) and CDSCO (Central Drugs Standard Control Organization), the guidelines call for the establishment of GTAEC (Gene Therapy Advisory and Evaluation Committee), whose function would be to evaluate proposals for scientific, clinical and ethical content and recommend changes or refinements.

The guidelines continues to prohibit germline gene editing based clinical trials and does not elaborate on a definition of therapeutic benefit. Is curing baldness therapeutic? Is deafness a disease? There are several ethical questions to the definition of disease and disorder which need to be addressed in this context. 

The guidelines call for the formation of disease-specific groups to recommend specific trial guidelines. However, the constitution of these groups does not include the necessary stakeholders - industry representatives or patient groups. 

The remaining sections are process-oriented, expanding on patient recruitment for trial and necessary documentation. 

It's Controversial

More room for SC/ST scientists in biotech bodies?

An RTI filed by a researcher has found that scientists from Scheduled Castes (SC) and Scheduled Tribes (ST) are grossly under-represented in scientific institutions funded by the Department of Biotechnology (DBT).

Several institutions have enough representation to meet the government prescribed criteria for reservation — 15% for SC and 7.5% for ST. But for job posts where there is no mandatory reservation, representation fall in low single digits.  The report has generated questions - how important is it to have more diversity on our institutional campuses? An earlier Compound Eye edition, had carried the observation of a colleague of noted biologist James Watson. He had suggested that if James Watson had been more exposed to accomplished women/men of race, perhaps he would not have made any racist comments. After that edition a few readers had written to me saying that our campuses should also be made more inclusive. 

We would definitely want the best scientists in our institutions. Reservations clearly would be detrimental to this goal. But our recruitment policies need to be revisited - besides getting the right skill set, there is preferential hiring of younger faculty members with an exposure to foreign training. As long as we continue to hire with these policies, our institutions will become increasingly homogenous in the kind of people we hire. Not necessarily in technical expertise, but in their career trajectories. To compensate for this, the government might just introduce more stringent reservation categories. It is definitely more prudent to more proactively revise our policies to make our institutions more diverse.  

Science in India

PMRF rollout: 

A report has found that 50 out of the 119 recipients of the PMRF scholarship will be pursuing their PhD at IISc. Students have been selected for PhD programmes at a total of 12 centrally funded institutions, including eight Indian Institutes of Technology (IITs) and three Indian Institutes of Science Education and Research besides IISc. 

Seventeen each have been selected for PhD at IIT-Madras and IIT Bombay, 15 at IIT-Kharagpur, seven at IIT-Delhi, four at IIT-Kanpur, three at IISER Pune, one each at IISER Thiruvananthapuram, Indian Institute of Mines (ISM) Dhanbad, IIT-BHU and IISER Bhopal.

The Prime Minister’s Research Fellowship (PMRF) scheme is aimed at attracting the talent pool of the country to doctoral (Ph.D.) programmes of Indian Institute of Science (IISc), Indian Institutes of Science Education & Research (IISERs) and Indian Institutes of Technology (IITs) for carrying out research in cutting edge science and technology domains, with focus on national priorities.

Perhaps the scheme should be expanded to include other central universities, so as to attract and foster high quality talent there as well. 

Meanwhile, remembering three stalwarts:

Rosalind Franklin: Marking her birth anniversary on 25th July, 1920. Need not say anything more about this extraordinary lady! 

Muthulakshmi Reddi: Born on 30 July 1886. A medical practitioner, social reformer, first female legislator and Padma Bhushan awardee. Daughter of a college principal and a Devadasi, Muthulakshmi led the introduction of legislation to abolish the devadasi system and child marriage. 

Jaipal Reddy: Veteran politician who passed away on 28th July 2019. A Lok Sabha member for 5 terms, he had a science connection. In 2014, as the Union Science and Technology Minister, he launched the Web portal which enables online submission of research and development (R&D) proposals while also contributing to greater transparency and efficiency in the decision-making process.

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Shambhavi Naik Research Fellow
shambhavi@takshashila.org.in
080 4372 5304

Takshashila Institution

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